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Propanthene
Propantheline Bromide
Propanthene
Propantheline Bromide
Indications
Peptic ulcer disease
Indication detailsView
Propantheline Bromide is indicated in the treatment of-
- Adjunctive therapy in the treatment of peptic ulcer (gastric and duodenal)
- Relief of the symptoms of gastritis (stomach upset, gastrointestinal bleeding, blood in vomit, blood in stool, persistent pain)
- Symptomatic treatment of the diarrhoea related irritable bowel syndrome (irritable colon, spastic colon, acute enterocolitis, functional Gl disorders etc)
- Urinary incontinence
- Control of salivation and enuresis
- Improves lactose intolerance
- Prevents excessive sweating (Hyperhidrosis)
Therapeutic classView
Anticholinergics (antimuscarinics)/ Anti-spasmodics
PharmacologyView
Propantheline Bromide acts by dual mechanism of action.
- Specific anticholinergic effect (antimuscarinic) at the acetylcholine-receptor sites
- Direct effect upon smooth muscle (musculotropic).
DosageView
The usual initial adult dose of Propantheline Bromide is 75 mg daily. One tablet 30 min before each meal (15 mg three times daily). Two tablets at bedtime Dosage adjustment should be made according to the patient's individual response and tolerance. But the maximum daily dosage should not exceed 120 mg.
Pediatric use: Safety and effectiveness in pediatric patients have not been established.
Pediatric use: Safety and effectiveness in pediatric patients have not been established.
Side effectsView
The adverse effects of Propantheline Bromide are usually dose-related and are usually reversible when the therapy is discontinued. Variable degrees of dry mouth, dry skin, mydriasis might be noted. Other reported adverse effects include urinary retention, nausea, vomiting, constipation, headache, nervousness, mental confusion etc.
ContraindicationsView
Propantheline Bromide is contraindicated in patients with-
- Hypersensitivity to Propantheline bromide or other anticholinergic agents;
- Glaucoma;
- Obstructive disease of the gastrointestinal tract (pyloroduodenal stenosis, paralytic ileus etc.);
- Obstructive uropathy (e.g. prostatic hypertrophy) intestinal atony of elderly;
- Myasthenia gravis.
PrecautionsView
Propantheline Bromide should be used with caution in the elderly and in all patients with autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac tachyarrhythmias, hypertension, since anticholinergics may aggravate this condition.
InteractionsView
Antacids or Absorbent Antidiarrhoeals may reduce the absorption of propantheline bromide, therefore resulting in a reduction of its therapeutic effectiveness. Therefore, take two to three hours apart from doses of propantheline bromide. Anticholinergics may delay absorption of other medication given concomitantly. Significant drug interaction also occurs with concomitant use of digoxin, haloperidol, corticosteroides, ketoconazole, levodopa, opioid analgesics, phenothiazines, urinary alkalizers.
Pregnancy & lactationView
Propantheline Bromide is in pregnancy category C. Animal reproduction studies have not been conducted with propantheline bromide. Propantheline bromide should be given to a pregnant woman only if clearly needed. It is not known whether this drug is excreted in milk. Because many drugs are excreted in milk, caution should be exercised when propantheline bromide is administered to a nursing woman. Suppression of lactation may occur with anticholinergic drugs.
Overdose effectsView
The symptoms of overdosage with Propantheline Bromide progress from an intensification of the usual side effects (from nausea and vomiting) to CNS disturbances (from restlessness and excitement to psychotic behaviour), circulatory changes, (flushing, fall in blood pressure, circulatory failure), respiratory failure, paralysis.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Propenta
Pantoprazole Sodium Sesquihydrate
Propenta
Pantoprazole Sodium Sesquihydrate
Indications
Zollinger-Ellison syndrome
Indication detailsView
Pantoprazole is indicated where suppression of acid secretion has therapeutic benefit; i.e
- Peptic ulcer diseases
- Gastroesophageal reflux diseases
- Ulcer induced by non-steroidal anti-inflammatory drugs (NSAIDs)
- Eradication of Helicobacter pylori (in combination with antibiotics)
- Zollinger-Ellison Syndrome
Therapeutic classView
Proton Pump Inhibitor
PharmacologyView
Pantoprazole is a proton pump inhibitor that suppresses the final step in gastric acid production by covalently binding to the H+/K+ATPase enzyme system at the surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus that persists longer than 24 hours.
DosageView
Oral:
IV Injection:
- Benign gastric ulcer: 40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed.
- Gastro-esophageal reflux disease: 20-40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed; maintenance dose is 20 mg daily, which may be increased to 40 mg daily.
- Duodenal ulcer: 40 mg daily in the morning for 2 weeks, continued for further 2 weeks if not fully healed.
- Duodenal ulcer associated with Helicobacter pylori: Pantoprazole is recommended at a dose of 40 mg twice daily in association with antimicrobial agents as detailed below: Amoxycillin 1 g and Clarithromycin 500 mg both twice daily for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice daily for one week.
- Prophylaxis of NSAID-associated gastric or duodenal ulcer: 20 mg daily for those require long-term NSAID treatment.
- Zollinger-Ellison Syndrome: Initially 80 mg once daily adjusted according to response (elderly max. 40 mg daily); daily doses above 80 mg given in 2 divided doses.
IV Injection:
- Duodenal ulcer and gastric ulcer: 40 mg once daily for 7-10 days
- Gastroesophageal reflux disease associated with a history of erosive esophagitis: 40 mg once daily for 7-10 days
- Prevention of rebleeding in peptic ulcer: IV 80 mg, followed by 8 mg/hour infusion for 72 hours
- Prophylaxis of acid aspiration: 80 mg IV every 12 h for 24 h, followed by 40mg every 12 hour
- Long-term management of Zollinger-Ellison Syndrome and other pathological hypersecretory conditions: 80 mg IV every 12 hours, may increase to 80 mg every 8 hours if needed, may titrate to higher doses depending on acid output.
Side effectsView
Pantoprazole is well tolerated in both short-term and long-term treatment. Headache and diarrhea are the common side effects and rarely included side effects are abdominal pain, flatulence, rash, insomnia and hyperglycemia.
ContraindicationsView
Pantoprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.
PrecautionsView
Patients should be cautioned that Pantoprazole tablet should not be split, chewed or crushed. Long-term therapy of Pantoprazole may lead to malabsorption of cyanocobalamin (Vitamin B12) or may increase the risk of osteoporosis related disorders.
InteractionsView
No significant drug interactions have been observed in clinical studies.
Pregnancy & lactationView
US FDA Pregnancy Category of Pantoprazole is B. There are, however, no adequate and well-controlled studies in pregnant woman. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Pantoprazole has been shown to be excreted in human milk. So, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.
Overdose effectsView
There are no known symptoms of overdosage in humans. Since Pantoprazole is highly protein bound, it is not readily dialyzable. Apart from symptomatic and supportive management, no specific therapy is recommended.
ReconstitutionView
Direction for use of IV injection: Pantoprazole lyophilized powder and 0.9% Sodium Chloride Injection is for intravenous administration only and must not be given by any other route. Pantoprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml 0.9% Sodium Chloride Injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes. Use only freshly prepared solution. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours.
Direction for use of IV infusion: Pantoprazole IV infusion should be given as an intravenous infusion over a period of approximately 15 minutes. Pantoprazole IV infusion should be reconstituted with 10 ml of 0.9% Sodium Chloride Injection and further diluted (admixed) with 0.9% Sodium Chloride Injection or 5% Dextrose or Lactated Ringer's Injection to a final volume of 100 ml. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours prior to further dilution. The admixed solution may be stored at room temperature (up to 30° C) and must be used within 24 hours from the time of initial reconstitution.
Direction for use of IV infusion: Pantoprazole IV infusion should be given as an intravenous infusion over a period of approximately 15 minutes. Pantoprazole IV infusion should be reconstituted with 10 ml of 0.9% Sodium Chloride Injection and further diluted (admixed) with 0.9% Sodium Chloride Injection or 5% Dextrose or Lactated Ringer's Injection to a final volume of 100 ml. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours prior to further dilution. The admixed solution may be stored at room temperature (up to 30° C) and must be used within 24 hours from the time of initial reconstitution.
StorageView
Keep in a dry place, away from light and heat. Keep out of the reach of children.
Propin
Omeprazole
Propin
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.
Propin
Omeprazole
Propin
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.
Propofol
Propofol
Propofol
Propofol
Indications
Sedation
Indication detailsView
Induction and maintenance of general anaesthesia. Sedation during intensive care. Sedation for surgical and diagnostic procedures.
Therapeutic classView
General (Intravenous) anesthetics
PharmacologyView
Propofol is a sedative-hypnotic agent for use in the induction and maintenance of anesthesia or sedation. Intravenous injection of a therapeutic dose of propofol produces hypnosis rapidly with minimal excitation, usually within 40 seconds from the start of an injection (the time for one arm-brain circulation). The action of propofol involves a positive modulation of the inhibitory function of the neurotransmitter gama-aminobutyric acid (GABA) through GABA-A receptors.
DosageView
Adults:
Induction of general anaesthesia: The dosage of Propofol should be titrated individually against the response of the patient. The ordinary initial dosage in adults is 40 mg (4 ml) by slow intravenous bolus injection at intervals of 10 seconds until the clinical signs show the onset of anaesthesia. The ordinary induction dose in healthy patient below 55 years of age is 2.2-2.5 mg/kg. A dose of 1.0-1.5 mg/kg is often sufficient for older patient. Lower doses, most often 20 mg (2 ml) at intervals of 10 seconds, are recommended for patient of ASA grades 3 and 4.Maintenance of general anaesthesia: Anaesthesia can be maintained by administering Propofol either by continuous infusion or by repeat bolus injections to maintain sufficient anaesthesia.
Continuous infusion: The required rate of infusion varies considerably between patients. At the onset of anaesthesia (during roughly the first 10-20 minutes), some patient may require a slightly higher infusion rate (8-10 mg/kg/h). However, sufficient anaesthesia is normally achieved by infusing 4-6 (up to 12) mg/kg/h of Propofol. Repeat bolus injections: 25-50 mg (2.5-5.0 ml) bolus injections, depending on response.
Sedation during intensive care: A bolus injection of 1.0-2.0 mg/kg should be given first, followed by continuous infusion adjusted according to required degree of sedation. An infusion rate of 0.3-4 mg/kg/h is usually sufficient.
Sedation for surgical and diagnostic procedures: Dosages shall be adjusted individually. Sufficient sedation for surgical and diagnostic procedures can usually be achieved by administering initially 0.5-1 mg/kg during 1-5 minutes, and maintained by continuous at a rate of 1-4.5 mg/kg/h. Bolus dose of 10-20 mg can be given in addition, should deeper sedation be suddenly required. Lower doses of Propofol are often sufficient for patient of ASA grades 3 and 4, and for older patient.
Children:
Propofol is not recommended for use in children less then 3 years of age as its safety has not been demonstrated.Induction of general anaesthesia: Dosage of Propofol in children shell be adjusted for weight and age. The mean induction dosage in children over 8 years is 2.5 mg/kg, given by slow intravenous injection until the clinical signs show the onset of anaesthesia. Younger children may need slightly higher doses of propofol per kilogram of weight. Lower dosages are recommended for children of ASA grades 3 and 4.
Maintenance of general anaesthesia: Anaesthesia can be maintained by administering Propofol either by continuous infusion or by repeat bolus injections. Dosage shall be adjusted individually, but an infusion rate of 9-15 mg/kg/h is usually sufficient to achieve satisfactory anaesthesia.
Sedation during intensive care, surgical diagnostic procedures: Propofol is not recommended for sedation in children as its efficacy and safety have not been demonstrated. Although no casual relationship has been established, serious adverse events (including fatalities) have been reported in cases, where propofol has been used against recommendations. Adverse events have most commonly been seen in children with respiratory tract infections given doses in excess of those recommended for adults.
AdministrationView
Method of administration: In order to reduce pain on injection, the induction dose of propofol may be mixed immediately before injection in the palstic syringe with lidocaine 10 mg/ml injection, in a ratio of 1 part of lidocaine injection for 20 parts of Propofol.
Propofol can be administered either undiluted or diluted for infusion. Before injection or dilution, each ampoule or vial shall be ispected for any irregularity. Should any changes be observed, the product shall not be used. Suitable equipment shall be used to ensure correct rate of infusion. Volumetric infusion pumps and syringe pumps, for example, are suitable for this purpose. The ordinary infusion set used alone is not sufficient to prevent accidential overdosage reliably enough.
Compatibility: Propofol may be diluted only with 5% dextrose infusion. Dilution shall not exceed 1 in 5 (containing 2 mg/ml Propofol) and shall be prepared in a PVC infusion bag or glass infusion bottle. If a PVC infusion bag is used, the bag should be full and the dilution be prepared by withdrawing a volume of infusion fluid and replacing it with an equal volume of Propofol. Special attention shall be paid to preparing the dilution aseptically, immediately before administration. Any diluted solution shall be used within 6 hours of preparation. Any remaining solution shall be discarded.
Propofol can be administered either undiluted or diluted for infusion. Before injection or dilution, each ampoule or vial shall be ispected for any irregularity. Should any changes be observed, the product shall not be used. Suitable equipment shall be used to ensure correct rate of infusion. Volumetric infusion pumps and syringe pumps, for example, are suitable for this purpose. The ordinary infusion set used alone is not sufficient to prevent accidential overdosage reliably enough.
Compatibility: Propofol may be diluted only with 5% dextrose infusion. Dilution shall not exceed 1 in 5 (containing 2 mg/ml Propofol) and shall be prepared in a PVC infusion bag or glass infusion bottle. If a PVC infusion bag is used, the bag should be full and the dilution be prepared by withdrawing a volume of infusion fluid and replacing it with an equal volume of Propofol. Special attention shall be paid to preparing the dilution aseptically, immediately before administration. Any diluted solution shall be used within 6 hours of preparation. Any remaining solution shall be discarded.
Side effectsView
Local: Propofol is normally well tolerated. Its most common undesirable effect is pain at the site of injection that can be reduced by mixing the preparation with lidocaine or by injecting it into one of the larger veins of the forearm or the intercubital fossa. Thrombosis and phlebitis are rare.
General: Hypotension and transient apnea may occur at the induction of anaesthesia, and may be severe especially in patients who are in a poor general condition. Epileptic movement, convulsions and dystonic reactions have been seen in rare cases. Pulmonary oedema has also been reported. Headache, nausea and, more rarely, vomiting may occur in some patients during recovery. Recovery may also be associated with another short period of impaired consciousness. Hypersensitivity has been reported in some cases, connected with anaphylactic symptoms such as marked hypotension, bronchospasm, oedema and facial erythema. Some cases of cardiac arrest have occurred in connection with the administration of propofol. In connection with long-term administration of propofol, green or reddish brown discolouration of urine may occur. This is caused by the quinol metabolites of propofol, and is not dangerous. As with other anaesthetics, altered sexual behaviour may occur.
General: Hypotension and transient apnea may occur at the induction of anaesthesia, and may be severe especially in patients who are in a poor general condition. Epileptic movement, convulsions and dystonic reactions have been seen in rare cases. Pulmonary oedema has also been reported. Headache, nausea and, more rarely, vomiting may occur in some patients during recovery. Recovery may also be associated with another short period of impaired consciousness. Hypersensitivity has been reported in some cases, connected with anaphylactic symptoms such as marked hypotension, bronchospasm, oedema and facial erythema. Some cases of cardiac arrest have occurred in connection with the administration of propofol. In connection with long-term administration of propofol, green or reddish brown discolouration of urine may occur. This is caused by the quinol metabolites of propofol, and is not dangerous. As with other anaesthetics, altered sexual behaviour may occur.
ContraindicationsView
Allergy to propofol or any other ingredient in the preparation.
PrecautionsView
Propofol should only be given by specialists in anaesthesiology or under their supervision. The physician performing a surgical or diagnostic procedure should not administer propofol. Facilities for resuscitation in case of any complication should be available at the treatment unit. During the administration of Propofol, patients shall be monitored continuously to observe possible hypotension, obstruction in the respiratory tract, hypoventilation or insufficient oxygen intake at a sufficiently early stage. Special attention shall be paid to patients sedated by Propofol for a surgical or diagnostic procedure, who are not artificially ventilated. Caution shall be taken in administering Propofol to patients with cardiac, respiratory, renal or hepatic insufficiency. Hypovolemic patients and those with poor general condition form another risk group.
Since propofol lacks vagolytic activity, bradycardia, even asystole, may occur. Intravenous administration of an anticholinergic agent before induction and during maintenance of anaesthesia should be considered, especially if propofol is used in conjunction with other agents likely to cause bradycardia and in situations where vagal tone is likely to predominate. Since Propofol is a lipid emulsion, appropriate care should be applied in patients with severe disorders of fat metabolism such as pathological hyperlipidemia. If Propofol is administered to a patient for whom excessive fat intake may be risky, blood lipid values shall be monitored and Propofol dosage decreased if necessary. If the patient is receiving other paranteral lipid emulsions in addition to Propofol, the amount of lipid in Propofol (0.1 g/ ml) shall be taken into account, when calculating the total intake of fat. In epileptic patients, propofol may lead to convulsions. The analgetic effect of propofol as such is insufficient. Analgetics shall be used to ensure sufficient analgesia. Full recovery from general anaesthesia shall be confirmed prior to discharge. It shall be noted that the aftermath of general anaesthesia may impair the patient's ability to understand instructions given postoperatively.
Since propofol lacks vagolytic activity, bradycardia, even asystole, may occur. Intravenous administration of an anticholinergic agent before induction and during maintenance of anaesthesia should be considered, especially if propofol is used in conjunction with other agents likely to cause bradycardia and in situations where vagal tone is likely to predominate. Since Propofol is a lipid emulsion, appropriate care should be applied in patients with severe disorders of fat metabolism such as pathological hyperlipidemia. If Propofol is administered to a patient for whom excessive fat intake may be risky, blood lipid values shall be monitored and Propofol dosage decreased if necessary. If the patient is receiving other paranteral lipid emulsions in addition to Propofol, the amount of lipid in Propofol (0.1 g/ ml) shall be taken into account, when calculating the total intake of fat. In epileptic patients, propofol may lead to convulsions. The analgetic effect of propofol as such is insufficient. Analgetics shall be used to ensure sufficient analgesia. Full recovery from general anaesthesia shall be confirmed prior to discharge. It shall be noted that the aftermath of general anaesthesia may impair the patient's ability to understand instructions given postoperatively.
InteractionsView
Propofol has been used in association with spinal and epidural anaesthesia as well as with various types of premedicants, muscle relaxants, inhalation anaesthetics and analgetics. No pharmacological incompatibility has been observed. Lower doses of Propofol may be sufficient in case Propofol is used as an adjunct to local anaesthetic techniques. In doses applied clinically, propofol will not inhibit the synthesis of adrenocortical hormones. Simultaneous administration of opiates may potentiate respiratory depression caused by Propofol.
Pregnancy & lactationView
Due to insufficient experience, propofol shall not be used during pregnancy. Propofol is rapidly distributed to the foetus and shall therefore not be used for obstetric anaesthesia. Safety to the neonate has not been established in cases, where propofol has been administered to lactating women.
Pediatric usageView
Use in children: Propofol is not recommended for use in children less then 3 years of age as its safety has not been demonstrated.
Overdose effectsView
Overdosage may cause cardiorespiratory depression. Respiratory depression should be treated by artificial ventilation with oxygen, and cardiovascular depression by lowering of the patient's head and elevating of his/her legs. Pressor agents and plasma expanders or Ringer-type electrolyte solutions may be used, if necessary.
ReconstitutionView
Propofol should not be mixed prior to intravenous injection with solutions or infusion fluids other than 5% dextrose or lidocaine 10 mg/ml injection.
StorageView
Propofol should be stored at a temperature not exceeding 25º C. It must not be frozen. Any unused solution shall be discarded.
Propofol MCT
Propofol
Propofol MCT
Propofol
Indications
Sedation
Indication detailsView
Induction and maintenance of general anaesthesia. Sedation during intensive care. Sedation for surgical and diagnostic procedures.
Therapeutic classView
General (Intravenous) anesthetics
PharmacologyView
Propofol is a sedative-hypnotic agent for use in the induction and maintenance of anesthesia or sedation. Intravenous injection of a therapeutic dose of propofol produces hypnosis rapidly with minimal excitation, usually within 40 seconds from the start of an injection (the time for one arm-brain circulation). The action of propofol involves a positive modulation of the inhibitory function of the neurotransmitter gama-aminobutyric acid (GABA) through GABA-A receptors.
DosageView
Adults:
Induction of general anaesthesia: The dosage of Propofol should be titrated individually against the response of the patient. The ordinary initial dosage in adults is 40 mg (4 ml) by slow intravenous bolus injection at intervals of 10 seconds until the clinical signs show the onset of anaesthesia. The ordinary induction dose in healthy patient below 55 years of age is 2.2-2.5 mg/kg. A dose of 1.0-1.5 mg/kg is often sufficient for older patient. Lower doses, most often 20 mg (2 ml) at intervals of 10 seconds, are recommended for patient of ASA grades 3 and 4.Maintenance of general anaesthesia: Anaesthesia can be maintained by administering Propofol either by continuous infusion or by repeat bolus injections to maintain sufficient anaesthesia.
Continuous infusion: The required rate of infusion varies considerably between patients. At the onset of anaesthesia (during roughly the first 10-20 minutes), some patient may require a slightly higher infusion rate (8-10 mg/kg/h). However, sufficient anaesthesia is normally achieved by infusing 4-6 (up to 12) mg/kg/h of Propofol. Repeat bolus injections: 25-50 mg (2.5-5.0 ml) bolus injections, depending on response.
Sedation during intensive care: A bolus injection of 1.0-2.0 mg/kg should be given first, followed by continuous infusion adjusted according to required degree of sedation. An infusion rate of 0.3-4 mg/kg/h is usually sufficient.
Sedation for surgical and diagnostic procedures: Dosages shall be adjusted individually. Sufficient sedation for surgical and diagnostic procedures can usually be achieved by administering initially 0.5-1 mg/kg during 1-5 minutes, and maintained by continuous at a rate of 1-4.5 mg/kg/h. Bolus dose of 10-20 mg can be given in addition, should deeper sedation be suddenly required. Lower doses of Propofol are often sufficient for patient of ASA grades 3 and 4, and for older patient.
Children:
Propofol is not recommended for use in children less then 3 years of age as its safety has not been demonstrated.Induction of general anaesthesia: Dosage of Propofol in children shell be adjusted for weight and age. The mean induction dosage in children over 8 years is 2.5 mg/kg, given by slow intravenous injection until the clinical signs show the onset of anaesthesia. Younger children may need slightly higher doses of propofol per kilogram of weight. Lower dosages are recommended for children of ASA grades 3 and 4.
Maintenance of general anaesthesia: Anaesthesia can be maintained by administering Propofol either by continuous infusion or by repeat bolus injections. Dosage shall be adjusted individually, but an infusion rate of 9-15 mg/kg/h is usually sufficient to achieve satisfactory anaesthesia.
Sedation during intensive care, surgical diagnostic procedures: Propofol is not recommended for sedation in children as its efficacy and safety have not been demonstrated. Although no casual relationship has been established, serious adverse events (including fatalities) have been reported in cases, where propofol has been used against recommendations. Adverse events have most commonly been seen in children with respiratory tract infections given doses in excess of those recommended for adults.
AdministrationView
Method of administration: In order to reduce pain on injection, the induction dose of propofol may be mixed immediately before injection in the palstic syringe with lidocaine 10 mg/ml injection, in a ratio of 1 part of lidocaine injection for 20 parts of Propofol.
Propofol can be administered either undiluted or diluted for infusion. Before injection or dilution, each ampoule or vial shall be ispected for any irregularity. Should any changes be observed, the product shall not be used. Suitable equipment shall be used to ensure correct rate of infusion. Volumetric infusion pumps and syringe pumps, for example, are suitable for this purpose. The ordinary infusion set used alone is not sufficient to prevent accidential overdosage reliably enough.
Compatibility: Propofol may be diluted only with 5% dextrose infusion. Dilution shall not exceed 1 in 5 (containing 2 mg/ml Propofol) and shall be prepared in a PVC infusion bag or glass infusion bottle. If a PVC infusion bag is used, the bag should be full and the dilution be prepared by withdrawing a volume of infusion fluid and replacing it with an equal volume of Propofol. Special attention shall be paid to preparing the dilution aseptically, immediately before administration. Any diluted solution shall be used within 6 hours of preparation. Any remaining solution shall be discarded.
Propofol can be administered either undiluted or diluted for infusion. Before injection or dilution, each ampoule or vial shall be ispected for any irregularity. Should any changes be observed, the product shall not be used. Suitable equipment shall be used to ensure correct rate of infusion. Volumetric infusion pumps and syringe pumps, for example, are suitable for this purpose. The ordinary infusion set used alone is not sufficient to prevent accidential overdosage reliably enough.
Compatibility: Propofol may be diluted only with 5% dextrose infusion. Dilution shall not exceed 1 in 5 (containing 2 mg/ml Propofol) and shall be prepared in a PVC infusion bag or glass infusion bottle. If a PVC infusion bag is used, the bag should be full and the dilution be prepared by withdrawing a volume of infusion fluid and replacing it with an equal volume of Propofol. Special attention shall be paid to preparing the dilution aseptically, immediately before administration. Any diluted solution shall be used within 6 hours of preparation. Any remaining solution shall be discarded.
Side effectsView
Local: Propofol is normally well tolerated. Its most common undesirable effect is pain at the site of injection that can be reduced by mixing the preparation with lidocaine or by injecting it into one of the larger veins of the forearm or the intercubital fossa. Thrombosis and phlebitis are rare.
General: Hypotension and transient apnea may occur at the induction of anaesthesia, and may be severe especially in patients who are in a poor general condition. Epileptic movement, convulsions and dystonic reactions have been seen in rare cases. Pulmonary oedema has also been reported. Headache, nausea and, more rarely, vomiting may occur in some patients during recovery. Recovery may also be associated with another short period of impaired consciousness. Hypersensitivity has been reported in some cases, connected with anaphylactic symptoms such as marked hypotension, bronchospasm, oedema and facial erythema. Some cases of cardiac arrest have occurred in connection with the administration of propofol. In connection with long-term administration of propofol, green or reddish brown discolouration of urine may occur. This is caused by the quinol metabolites of propofol, and is not dangerous. As with other anaesthetics, altered sexual behaviour may occur.
General: Hypotension and transient apnea may occur at the induction of anaesthesia, and may be severe especially in patients who are in a poor general condition. Epileptic movement, convulsions and dystonic reactions have been seen in rare cases. Pulmonary oedema has also been reported. Headache, nausea and, more rarely, vomiting may occur in some patients during recovery. Recovery may also be associated with another short period of impaired consciousness. Hypersensitivity has been reported in some cases, connected with anaphylactic symptoms such as marked hypotension, bronchospasm, oedema and facial erythema. Some cases of cardiac arrest have occurred in connection with the administration of propofol. In connection with long-term administration of propofol, green or reddish brown discolouration of urine may occur. This is caused by the quinol metabolites of propofol, and is not dangerous. As with other anaesthetics, altered sexual behaviour may occur.
ContraindicationsView
Allergy to propofol or any other ingredient in the preparation.
PrecautionsView
Propofol should only be given by specialists in anaesthesiology or under their supervision. The physician performing a surgical or diagnostic procedure should not administer propofol. Facilities for resuscitation in case of any complication should be available at the treatment unit. During the administration of Propofol, patients shall be monitored continuously to observe possible hypotension, obstruction in the respiratory tract, hypoventilation or insufficient oxygen intake at a sufficiently early stage. Special attention shall be paid to patients sedated by Propofol for a surgical or diagnostic procedure, who are not artificially ventilated. Caution shall be taken in administering Propofol to patients with cardiac, respiratory, renal or hepatic insufficiency. Hypovolemic patients and those with poor general condition form another risk group.
Since propofol lacks vagolytic activity, bradycardia, even asystole, may occur. Intravenous administration of an anticholinergic agent before induction and during maintenance of anaesthesia should be considered, especially if propofol is used in conjunction with other agents likely to cause bradycardia and in situations where vagal tone is likely to predominate. Since Propofol is a lipid emulsion, appropriate care should be applied in patients with severe disorders of fat metabolism such as pathological hyperlipidemia. If Propofol is administered to a patient for whom excessive fat intake may be risky, blood lipid values shall be monitored and Propofol dosage decreased if necessary. If the patient is receiving other paranteral lipid emulsions in addition to Propofol, the amount of lipid in Propofol (0.1 g/ ml) shall be taken into account, when calculating the total intake of fat. In epileptic patients, propofol may lead to convulsions. The analgetic effect of propofol as such is insufficient. Analgetics shall be used to ensure sufficient analgesia. Full recovery from general anaesthesia shall be confirmed prior to discharge. It shall be noted that the aftermath of general anaesthesia may impair the patient's ability to understand instructions given postoperatively.
Since propofol lacks vagolytic activity, bradycardia, even asystole, may occur. Intravenous administration of an anticholinergic agent before induction and during maintenance of anaesthesia should be considered, especially if propofol is used in conjunction with other agents likely to cause bradycardia and in situations where vagal tone is likely to predominate. Since Propofol is a lipid emulsion, appropriate care should be applied in patients with severe disorders of fat metabolism such as pathological hyperlipidemia. If Propofol is administered to a patient for whom excessive fat intake may be risky, blood lipid values shall be monitored and Propofol dosage decreased if necessary. If the patient is receiving other paranteral lipid emulsions in addition to Propofol, the amount of lipid in Propofol (0.1 g/ ml) shall be taken into account, when calculating the total intake of fat. In epileptic patients, propofol may lead to convulsions. The analgetic effect of propofol as such is insufficient. Analgetics shall be used to ensure sufficient analgesia. Full recovery from general anaesthesia shall be confirmed prior to discharge. It shall be noted that the aftermath of general anaesthesia may impair the patient's ability to understand instructions given postoperatively.
InteractionsView
Propofol has been used in association with spinal and epidural anaesthesia as well as with various types of premedicants, muscle relaxants, inhalation anaesthetics and analgetics. No pharmacological incompatibility has been observed. Lower doses of Propofol may be sufficient in case Propofol is used as an adjunct to local anaesthetic techniques. In doses applied clinically, propofol will not inhibit the synthesis of adrenocortical hormones. Simultaneous administration of opiates may potentiate respiratory depression caused by Propofol.
Pregnancy & lactationView
Due to insufficient experience, propofol shall not be used during pregnancy. Propofol is rapidly distributed to the foetus and shall therefore not be used for obstetric anaesthesia. Safety to the neonate has not been established in cases, where propofol has been administered to lactating women.
Pediatric usageView
Use in children: Propofol is not recommended for use in children less then 3 years of age as its safety has not been demonstrated.
Overdose effectsView
Overdosage may cause cardiorespiratory depression. Respiratory depression should be treated by artificial ventilation with oxygen, and cardiovascular depression by lowering of the patient's head and elevating of his/her legs. Pressor agents and plasma expanders or Ringer-type electrolyte solutions may be used, if necessary.
ReconstitutionView
Propofol should not be mixed prior to intravenous injection with solutions or infusion fluids other than 5% dextrose or lidocaine 10 mg/ml injection.
StorageView
Propofol should be stored at a temperature not exceeding 25º C. It must not be frozen. Any unused solution shall be discarded.
Propofol-Lipuro
Propofol
Propofol-Lipuro
Propofol
Indications
Sedation
Indication detailsView
Induction and maintenance of general anaesthesia. Sedation during intensive care. Sedation for surgical and diagnostic procedures.
Therapeutic classView
General (Intravenous) anesthetics
PharmacologyView
Propofol is a sedative-hypnotic agent for use in the induction and maintenance of anesthesia or sedation. Intravenous injection of a therapeutic dose of propofol produces hypnosis rapidly with minimal excitation, usually within 40 seconds from the start of an injection (the time for one arm-brain circulation). The action of propofol involves a positive modulation of the inhibitory function of the neurotransmitter gama-aminobutyric acid (GABA) through GABA-A receptors.
DosageView
Adults:
Induction of general anaesthesia: The dosage of Propofol should be titrated individually against the response of the patient. The ordinary initial dosage in adults is 40 mg (4 ml) by slow intravenous bolus injection at intervals of 10 seconds until the clinical signs show the onset of anaesthesia. The ordinary induction dose in healthy patient below 55 years of age is 2.2-2.5 mg/kg. A dose of 1.0-1.5 mg/kg is often sufficient for older patient. Lower doses, most often 20 mg (2 ml) at intervals of 10 seconds, are recommended for patient of ASA grades 3 and 4.Maintenance of general anaesthesia: Anaesthesia can be maintained by administering Propofol either by continuous infusion or by repeat bolus injections to maintain sufficient anaesthesia.
Continuous infusion: The required rate of infusion varies considerably between patients. At the onset of anaesthesia (during roughly the first 10-20 minutes), some patient may require a slightly higher infusion rate (8-10 mg/kg/h). However, sufficient anaesthesia is normally achieved by infusing 4-6 (up to 12) mg/kg/h of Propofol. Repeat bolus injections: 25-50 mg (2.5-5.0 ml) bolus injections, depending on response.
Sedation during intensive care: A bolus injection of 1.0-2.0 mg/kg should be given first, followed by continuous infusion adjusted according to required degree of sedation. An infusion rate of 0.3-4 mg/kg/h is usually sufficient.
Sedation for surgical and diagnostic procedures: Dosages shall be adjusted individually. Sufficient sedation for surgical and diagnostic procedures can usually be achieved by administering initially 0.5-1 mg/kg during 1-5 minutes, and maintained by continuous at a rate of 1-4.5 mg/kg/h. Bolus dose of 10-20 mg can be given in addition, should deeper sedation be suddenly required. Lower doses of Propofol are often sufficient for patient of ASA grades 3 and 4, and for older patient.
Children:
Propofol is not recommended for use in children less then 3 years of age as its safety has not been demonstrated.Induction of general anaesthesia: Dosage of Propofol in children shell be adjusted for weight and age. The mean induction dosage in children over 8 years is 2.5 mg/kg, given by slow intravenous injection until the clinical signs show the onset of anaesthesia. Younger children may need slightly higher doses of propofol per kilogram of weight. Lower dosages are recommended for children of ASA grades 3 and 4.
Maintenance of general anaesthesia: Anaesthesia can be maintained by administering Propofol either by continuous infusion or by repeat bolus injections. Dosage shall be adjusted individually, but an infusion rate of 9-15 mg/kg/h is usually sufficient to achieve satisfactory anaesthesia.
Sedation during intensive care, surgical diagnostic procedures: Propofol is not recommended for sedation in children as its efficacy and safety have not been demonstrated. Although no casual relationship has been established, serious adverse events (including fatalities) have been reported in cases, where propofol has been used against recommendations. Adverse events have most commonly been seen in children with respiratory tract infections given doses in excess of those recommended for adults.
AdministrationView
Method of administration: In order to reduce pain on injection, the induction dose of propofol may be mixed immediately before injection in the palstic syringe with lidocaine 10 mg/ml injection, in a ratio of 1 part of lidocaine injection for 20 parts of Propofol.
Propofol can be administered either undiluted or diluted for infusion. Before injection or dilution, each ampoule or vial shall be ispected for any irregularity. Should any changes be observed, the product shall not be used. Suitable equipment shall be used to ensure correct rate of infusion. Volumetric infusion pumps and syringe pumps, for example, are suitable for this purpose. The ordinary infusion set used alone is not sufficient to prevent accidential overdosage reliably enough.
Compatibility: Propofol may be diluted only with 5% dextrose infusion. Dilution shall not exceed 1 in 5 (containing 2 mg/ml Propofol) and shall be prepared in a PVC infusion bag or glass infusion bottle. If a PVC infusion bag is used, the bag should be full and the dilution be prepared by withdrawing a volume of infusion fluid and replacing it with an equal volume of Propofol. Special attention shall be paid to preparing the dilution aseptically, immediately before administration. Any diluted solution shall be used within 6 hours of preparation. Any remaining solution shall be discarded.
Propofol can be administered either undiluted or diluted for infusion. Before injection or dilution, each ampoule or vial shall be ispected for any irregularity. Should any changes be observed, the product shall not be used. Suitable equipment shall be used to ensure correct rate of infusion. Volumetric infusion pumps and syringe pumps, for example, are suitable for this purpose. The ordinary infusion set used alone is not sufficient to prevent accidential overdosage reliably enough.
Compatibility: Propofol may be diluted only with 5% dextrose infusion. Dilution shall not exceed 1 in 5 (containing 2 mg/ml Propofol) and shall be prepared in a PVC infusion bag or glass infusion bottle. If a PVC infusion bag is used, the bag should be full and the dilution be prepared by withdrawing a volume of infusion fluid and replacing it with an equal volume of Propofol. Special attention shall be paid to preparing the dilution aseptically, immediately before administration. Any diluted solution shall be used within 6 hours of preparation. Any remaining solution shall be discarded.
Side effectsView
Local: Propofol is normally well tolerated. Its most common undesirable effect is pain at the site of injection that can be reduced by mixing the preparation with lidocaine or by injecting it into one of the larger veins of the forearm or the intercubital fossa. Thrombosis and phlebitis are rare.
General: Hypotension and transient apnea may occur at the induction of anaesthesia, and may be severe especially in patients who are in a poor general condition. Epileptic movement, convulsions and dystonic reactions have been seen in rare cases. Pulmonary oedema has also been reported. Headache, nausea and, more rarely, vomiting may occur in some patients during recovery. Recovery may also be associated with another short period of impaired consciousness. Hypersensitivity has been reported in some cases, connected with anaphylactic symptoms such as marked hypotension, bronchospasm, oedema and facial erythema. Some cases of cardiac arrest have occurred in connection with the administration of propofol. In connection with long-term administration of propofol, green or reddish brown discolouration of urine may occur. This is caused by the quinol metabolites of propofol, and is not dangerous. As with other anaesthetics, altered sexual behaviour may occur.
General: Hypotension and transient apnea may occur at the induction of anaesthesia, and may be severe especially in patients who are in a poor general condition. Epileptic movement, convulsions and dystonic reactions have been seen in rare cases. Pulmonary oedema has also been reported. Headache, nausea and, more rarely, vomiting may occur in some patients during recovery. Recovery may also be associated with another short period of impaired consciousness. Hypersensitivity has been reported in some cases, connected with anaphylactic symptoms such as marked hypotension, bronchospasm, oedema and facial erythema. Some cases of cardiac arrest have occurred in connection with the administration of propofol. In connection with long-term administration of propofol, green or reddish brown discolouration of urine may occur. This is caused by the quinol metabolites of propofol, and is not dangerous. As with other anaesthetics, altered sexual behaviour may occur.
ContraindicationsView
Allergy to propofol or any other ingredient in the preparation.
PrecautionsView
Propofol should only be given by specialists in anaesthesiology or under their supervision. The physician performing a surgical or diagnostic procedure should not administer propofol. Facilities for resuscitation in case of any complication should be available at the treatment unit. During the administration of Propofol, patients shall be monitored continuously to observe possible hypotension, obstruction in the respiratory tract, hypoventilation or insufficient oxygen intake at a sufficiently early stage. Special attention shall be paid to patients sedated by Propofol for a surgical or diagnostic procedure, who are not artificially ventilated. Caution shall be taken in administering Propofol to patients with cardiac, respiratory, renal or hepatic insufficiency. Hypovolemic patients and those with poor general condition form another risk group.
Since propofol lacks vagolytic activity, bradycardia, even asystole, may occur. Intravenous administration of an anticholinergic agent before induction and during maintenance of anaesthesia should be considered, especially if propofol is used in conjunction with other agents likely to cause bradycardia and in situations where vagal tone is likely to predominate. Since Propofol is a lipid emulsion, appropriate care should be applied in patients with severe disorders of fat metabolism such as pathological hyperlipidemia. If Propofol is administered to a patient for whom excessive fat intake may be risky, blood lipid values shall be monitored and Propofol dosage decreased if necessary. If the patient is receiving other paranteral lipid emulsions in addition to Propofol, the amount of lipid in Propofol (0.1 g/ ml) shall be taken into account, when calculating the total intake of fat. In epileptic patients, propofol may lead to convulsions. The analgetic effect of propofol as such is insufficient. Analgetics shall be used to ensure sufficient analgesia. Full recovery from general anaesthesia shall be confirmed prior to discharge. It shall be noted that the aftermath of general anaesthesia may impair the patient's ability to understand instructions given postoperatively.
Since propofol lacks vagolytic activity, bradycardia, even asystole, may occur. Intravenous administration of an anticholinergic agent before induction and during maintenance of anaesthesia should be considered, especially if propofol is used in conjunction with other agents likely to cause bradycardia and in situations where vagal tone is likely to predominate. Since Propofol is a lipid emulsion, appropriate care should be applied in patients with severe disorders of fat metabolism such as pathological hyperlipidemia. If Propofol is administered to a patient for whom excessive fat intake may be risky, blood lipid values shall be monitored and Propofol dosage decreased if necessary. If the patient is receiving other paranteral lipid emulsions in addition to Propofol, the amount of lipid in Propofol (0.1 g/ ml) shall be taken into account, when calculating the total intake of fat. In epileptic patients, propofol may lead to convulsions. The analgetic effect of propofol as such is insufficient. Analgetics shall be used to ensure sufficient analgesia. Full recovery from general anaesthesia shall be confirmed prior to discharge. It shall be noted that the aftermath of general anaesthesia may impair the patient's ability to understand instructions given postoperatively.
InteractionsView
Propofol has been used in association with spinal and epidural anaesthesia as well as with various types of premedicants, muscle relaxants, inhalation anaesthetics and analgetics. No pharmacological incompatibility has been observed. Lower doses of Propofol may be sufficient in case Propofol is used as an adjunct to local anaesthetic techniques. In doses applied clinically, propofol will not inhibit the synthesis of adrenocortical hormones. Simultaneous administration of opiates may potentiate respiratory depression caused by Propofol.
Pregnancy & lactationView
Due to insufficient experience, propofol shall not be used during pregnancy. Propofol is rapidly distributed to the foetus and shall therefore not be used for obstetric anaesthesia. Safety to the neonate has not been established in cases, where propofol has been administered to lactating women.
Pediatric usageView
Use in children: Propofol is not recommended for use in children less then 3 years of age as its safety has not been demonstrated.
Overdose effectsView
Overdosage may cause cardiorespiratory depression. Respiratory depression should be treated by artificial ventilation with oxygen, and cardiovascular depression by lowering of the patient's head and elevating of his/her legs. Pressor agents and plasma expanders or Ringer-type electrolyte solutions may be used, if necessary.
ReconstitutionView
Propofol should not be mixed prior to intravenous injection with solutions or infusion fluids other than 5% dextrose or lidocaine 10 mg/ml injection.
StorageView
Propofol should be stored at a temperature not exceeding 25º C. It must not be frozen. Any unused solution shall be discarded.
Propranol
Propranolol Hydrochloride
Propranol
Propranolol Hydrochloride
Indications
Tuberculosis
Indication detailsView
Propranolol is indicated in:
- Essential hypertension
- Angina pectoris
- Cardiac arrhythmia
- Thyrotoxicosis
- Anxiety
- Prophylaxis of migraine, etc.
Therapeutic classView
Beta-adrenoceptor blocking drugs, Beta-blockers
PharmacologyView
Propranolol Hydrochloride is a B-adrenergic receptor blocking drug which is widely used in hypertension and angina pectoris. Propranolol antagonizes catecholamines at B-adrenergic receptors, thus prevents excess rate and force of contraction of the heart and decreases the excess consumption of oxygen by the heart.
Propranolol is almost completely absorbed from the gastrointestinal tract, but a portion is immediately metabolized by the liver when passing through the portal circulation. Peak plasma concentration occurs in 1 to 1.5 hours after oral administration. The plasma half-life of propranolol is from 3 to 6 hours. The metabolites of propranolol are excreted through the urine.
Propranolol is almost completely absorbed from the gastrointestinal tract, but a portion is immediately metabolized by the liver when passing through the portal circulation. Peak plasma concentration occurs in 1 to 1.5 hours after oral administration. The plasma half-life of propranolol is from 3 to 6 hours. The metabolites of propranolol are excreted through the urine.
DosageView
Adult (above 18 years):
- Hypertension: Initially 80 mg twice daily, may be increased at weekly intervals and then maintenance dose of 160-320 mg daily is recommended.
- Angina pectoris: Initially 40 mg 2-3 times daily and then maintenance dose of 120-240 mg daily is given.
- Thyrotoxicosis: 10-40 mg, 3-4 times daily is given.
- Anxiety: 40 mg once daily, may be increased to three times daily.
- Prophylaxis of migraine: Initially 40 mg 2-3 times daily; then maintenance dose of 80-160 mg daily is recommended.
- Neonate: 0.25-0.5 mg/kg 3 times daily, adjusted according to response.
- Child 1 month: 12 years: 0.25-1 mg/kg 3 times daily, maximum dose 5 mg/kg daily in divided dose.
- Child 12-18 years: initially 80 mg twice daily, maintain 160-320 mg daily.
Side effectsView
Cold extremities, lassitude, nausea, dizziness, insomnia, paresthesia etc.
ContraindicationsView
Bronchospasm, cardiogenic shock, second or third degree heart block, diabetes mellitus etc.
PrecautionsView
It should be taken with caution in hepatic and renal impairment, pregnancy and lactating mother.
InteractionsView
Patients receiving verapamil, salbutamol, Levosalbutamol, ergot alkaloids, lidocain, phenobarbital drugs should be closely observed during therapy.
Pregnancy & lactationView
Pregnancy category C, should not be used in pregnant women. Propranolol is excreted in human milk. Caution should be taken when propranolol is administered to a nursing mother.
StorageView
Store in a cool and dry place, protected from light.
Propranol
Propranolol Hydrochloride
Propranol
Propranolol Hydrochloride
Indications
Tuberculosis
Indication detailsView
Propranolol is indicated in:
- Essential hypertension
- Angina pectoris
- Cardiac arrhythmia
- Thyrotoxicosis
- Anxiety
- Prophylaxis of migraine, etc.
Therapeutic classView
Beta-adrenoceptor blocking drugs, Beta-blockers
PharmacologyView
Propranolol Hydrochloride is a B-adrenergic receptor blocking drug which is widely used in hypertension and angina pectoris. Propranolol antagonizes catecholamines at B-adrenergic receptors, thus prevents excess rate and force of contraction of the heart and decreases the excess consumption of oxygen by the heart.
Propranolol is almost completely absorbed from the gastrointestinal tract, but a portion is immediately metabolized by the liver when passing through the portal circulation. Peak plasma concentration occurs in 1 to 1.5 hours after oral administration. The plasma half-life of propranolol is from 3 to 6 hours. The metabolites of propranolol are excreted through the urine.
Propranolol is almost completely absorbed from the gastrointestinal tract, but a portion is immediately metabolized by the liver when passing through the portal circulation. Peak plasma concentration occurs in 1 to 1.5 hours after oral administration. The plasma half-life of propranolol is from 3 to 6 hours. The metabolites of propranolol are excreted through the urine.
DosageView
Adult (above 18 years):
- Hypertension: Initially 80 mg twice daily, may be increased at weekly intervals and then maintenance dose of 160-320 mg daily is recommended.
- Angina pectoris: Initially 40 mg 2-3 times daily and then maintenance dose of 120-240 mg daily is given.
- Thyrotoxicosis: 10-40 mg, 3-4 times daily is given.
- Anxiety: 40 mg once daily, may be increased to three times daily.
- Prophylaxis of migraine: Initially 40 mg 2-3 times daily; then maintenance dose of 80-160 mg daily is recommended.
- Neonate: 0.25-0.5 mg/kg 3 times daily, adjusted according to response.
- Child 1 month: 12 years: 0.25-1 mg/kg 3 times daily, maximum dose 5 mg/kg daily in divided dose.
- Child 12-18 years: initially 80 mg twice daily, maintain 160-320 mg daily.
Side effectsView
Cold extremities, lassitude, nausea, dizziness, insomnia, paresthesia etc.
ContraindicationsView
Bronchospasm, cardiogenic shock, second or third degree heart block, diabetes mellitus etc.
PrecautionsView
It should be taken with caution in hepatic and renal impairment, pregnancy and lactating mother.
InteractionsView
Patients receiving verapamil, salbutamol, Levosalbutamol, ergot alkaloids, lidocain, phenobarbital drugs should be closely observed during therapy.
Pregnancy & lactationView
Pregnancy category C, should not be used in pregnant women. Propranolol is excreted in human milk. Caution should be taken when propranolol is administered to a nursing mother.
StorageView
Store in a cool and dry place, protected from light.
Prosalic
Betamethasone Dipropionate + Salicylic Acid
Prosalic
Betamethasone Dipropionate + Salicylic Acid
Indications
Seborrhea
Indication detailsView
This Scalp preparation is used to treat inflammatory, dry and scaly skin disorders, such as Eczema, Psoriasis.
Therapeutic classView
Topical anti-inflammatory preparations
PharmacologyView
Betamethasone Dipropionate is a glucocorticoid which have primarily anti-inflammatory and immunosuppressive effects and Salicylic Acid which has keratolytic properties and is applied topically in the treatment of hyperkeratotic. Keratolytic action helps to facilitate the penetration of the corticosteroids easily and Betamethasone Dipropionate is an effective treatment of dermatoses because of their anti-inflammatory, antipruritic and vasoconstrictive actions.
DosageView
Scalp Ointment-
- Adults: Once twice daily. In most cases, the ointment should be applied to the affected area twice daily for two weeks and is reviewed at that time. The maximum weekly dose should not exceed 60 gm.
- Children: Dosage in children should be limited to 5 days.
- Apply few drops of this scalp lotion to the affected area and massage gently and thoroughly onto the scalp or skin. The usual frequency of application is twice daily, in the morning and at night.
Side effectsView
Side effects that have been reported with the application of topical corticosteroids include burning, itching, irritation, dryness, hypopigmentation, perioral dermatitis and allergic contact dermatitis.
ContraindicationsView
Contraindicated to the hypersensitivity to any of the ingredients of this Scalp preparation. Also contraindicated to use in tuberculosis and most viral lesions of the skin, particularly herpes simplex, vacinia, varicella. This Scalp preparation should not be used in fungal or bacterial skin infections.
PrecautionsView
These drugs should not be used in or near the eyes. This Scalp preparation should not be used in various skin infections (Bacterial, Viral or Fungal). If irritation and sensitization develop with the use of this Scalp preparation, treatment should be discontinued. Application of Salicylic Acid to open wounds or damaged skin should be avoided. Long-term continuous therapy should be avoided in all patients irrespective of age.
InteractionsView
If other drugs or over-the-counter products use at the same time, this may increase the side effects or cause drug not to work properly. This Scalp preparation may interact with the following products such as Acetaminophen, Atropine, Carbonic anhydrase inhibitors, Chlorpropamide, Glucocorticoids.
Pregnancy & lactationView
It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and should not be used for prolonged periods of time in pregnant patients. It is not known this drug is secreted in human milk.
StorageView
Store in a cool & dry place, protected from light and keep out of the reach of children.
Prosan
Losartan Potassium
Prosan
Losartan Potassium
Indications
Stroke
Indication detailsView
Hypertension: Losartan Potassium is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents (eg. thiazide diuretics).
Renal Protection in Type-2 Diabetic Patients with Proteinuria: Losartan Potassium is indicated to delay the progression of renal disease in hypertensive type-2 diabetics with proteinuria, defined as urinary albumin to creatinine ratio >300 mg/g.
Renal Protection in Type-2 Diabetic Patients with Proteinuria: Losartan Potassium is indicated to delay the progression of renal disease in hypertensive type-2 diabetics with proteinuria, defined as urinary albumin to creatinine ratio >300 mg/g.
Therapeutic classView
Angiotensin-ll receptor blocker
PharmacologyView
Losartan Potassium is the first non-peptide orally active angiotensin II receptor blocker. It binds to the AT1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland, kidneys and the heart) and reduces several important biological actions including vasoconstriction and the release of aldosterone responsible for hypertension.
DosageView
The usual starting and maintenance dose is 50 mg once daily for most patients. If the antihypertensive effect using 50 mg once daily is inadequate, 25 mg twice daily is recommended prior to increasing the dose. For patients with intravascular volume-depletion (e.g., those treated with high-dose diuretics), a starting dose of 25 mg once daily should be considered. Losartan Potassium can be administered once or twice daily. The total daily dose ranges from 25 mg to 100 mg.
Side effectsView
The side effects with the use of Losartan Potassium are mild and transient in nature. The most common side effects are dizziness, diarrhea, nasal congestion, cough, upper respiratory infection. Other side effects are fatigue, oedema, abdominal pain, chest pain, nausea, headache & pharyngitis.
ContraindicationsView
Losartan Potassium is contraindicated in pregnant women and in patients who are hypersensitive to any component of this product. Losartan Potassium should not be administered with Aliskiren in patients with diabetes.
PrecautionsView
Use of Losartan Potassium during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. In patients who are intravascularly volume-depleted (e.g., those treated with high-dose diuretics), symptomatic hypotension may occur. Plasma concentration of Losartan Potassium is significantly increased in cirrhotic patients. Changes in renal function including renal failure have been reported in renal impaired patient.
InteractionsView
Rifampicin and fluconazole reduce levels of active metabolite of Losartan Potassium. Concomitant use of Losartan Potassium and hydrochlorothiazide may lead to potentiation of the antihypertensive effects. Concomitant use of potassium-sparing diuretics (eg, spironolactone, triamterene, amiloride), potassium supplements or salt substitutes containing potassium may lead to increases in serum potassium. The antihypertensive effect of losartan may be attenuated by the non-steroidal anti-inflammatory drug indomethacin. The use of ACE-inhibitor, angiotensin receptor antagonist, an anti-inflammatory drug and a thiazide diuretic at the same time increases the risk of renal impairment.
Pregnancy & lactationView
Pregnancy Category D. The risk to the fetus increases if Losartan Potassium is administered during the second or third trimesters of pregnancy. It is not known whether Losartan Potassium is excreted in human milk, as many drugs are excreted in human milk and because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
StorageView
keep in a dry place away from light and heat. Keep out of the reach of children.
Prosan
Losartan Potassium
Prosan
Losartan Potassium
Indications
Stroke
Indication detailsView
Hypertension: Losartan Potassium is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents (eg. thiazide diuretics).
Renal Protection in Type-2 Diabetic Patients with Proteinuria: Losartan Potassium is indicated to delay the progression of renal disease in hypertensive type-2 diabetics with proteinuria, defined as urinary albumin to creatinine ratio >300 mg/g.
Renal Protection in Type-2 Diabetic Patients with Proteinuria: Losartan Potassium is indicated to delay the progression of renal disease in hypertensive type-2 diabetics with proteinuria, defined as urinary albumin to creatinine ratio >300 mg/g.
Therapeutic classView
Angiotensin-ll receptor blocker
PharmacologyView
Losartan Potassium is the first non-peptide orally active angiotensin II receptor blocker. It binds to the AT1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland, kidneys and the heart) and reduces several important biological actions including vasoconstriction and the release of aldosterone responsible for hypertension.
DosageView
The usual starting and maintenance dose is 50 mg once daily for most patients. If the antihypertensive effect using 50 mg once daily is inadequate, 25 mg twice daily is recommended prior to increasing the dose. For patients with intravascular volume-depletion (e.g., those treated with high-dose diuretics), a starting dose of 25 mg once daily should be considered. Losartan Potassium can be administered once or twice daily. The total daily dose ranges from 25 mg to 100 mg.
Side effectsView
The side effects with the use of Losartan Potassium are mild and transient in nature. The most common side effects are dizziness, diarrhea, nasal congestion, cough, upper respiratory infection. Other side effects are fatigue, oedema, abdominal pain, chest pain, nausea, headache & pharyngitis.
ContraindicationsView
Losartan Potassium is contraindicated in pregnant women and in patients who are hypersensitive to any component of this product. Losartan Potassium should not be administered with Aliskiren in patients with diabetes.
PrecautionsView
Use of Losartan Potassium during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. In patients who are intravascularly volume-depleted (e.g., those treated with high-dose diuretics), symptomatic hypotension may occur. Plasma concentration of Losartan Potassium is significantly increased in cirrhotic patients. Changes in renal function including renal failure have been reported in renal impaired patient.
InteractionsView
Rifampicin and fluconazole reduce levels of active metabolite of Losartan Potassium. Concomitant use of Losartan Potassium and hydrochlorothiazide may lead to potentiation of the antihypertensive effects. Concomitant use of potassium-sparing diuretics (eg, spironolactone, triamterene, amiloride), potassium supplements or salt substitutes containing potassium may lead to increases in serum potassium. The antihypertensive effect of losartan may be attenuated by the non-steroidal anti-inflammatory drug indomethacin. The use of ACE-inhibitor, angiotensin receptor antagonist, an anti-inflammatory drug and a thiazide diuretic at the same time increases the risk of renal impairment.
Pregnancy & lactationView
Pregnancy Category D. The risk to the fetus increases if Losartan Potassium is administered during the second or third trimesters of pregnancy. It is not known whether Losartan Potassium is excreted in human milk, as many drugs are excreted in human milk and because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
StorageView
keep in a dry place away from light and heat. Keep out of the reach of children.
Prosan HZ
Losartan Potassium + Hydrochlorothiazide
Prosan HZ
Losartan Potassium + Hydrochlorothiazide
Indications
Stroke
Indication detailsView
This is indicated for the treatment of hypertension. It is also indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy.
Therapeutic classView
Combined antihypertensive preparations
PharmacologyView
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Losartan and its principal active metabolite block the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that losartan is a reversible, competitive inhibitor of the AT1 receptor. Neither Losartan nor its active metabolite inhibits ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin); nor do they bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of Sodium and Chloride in approximately equivalent amounts. Indirectly, the diuretic action of Hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in Aldosterone secretion, increases in urinary Potassium loss, and decreases in serum Potassium. The renin-aldosterone link is mediated by angiotensin II, so co-administration of an angiotensin II receptor antagonist tends to reverse the Potassium loss associated with these diuretics.
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of Sodium and Chloride in approximately equivalent amounts. Indirectly, the diuretic action of Hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in Aldosterone secretion, increases in urinary Potassium loss, and decreases in serum Potassium. The renin-aldosterone link is mediated by angiotensin II, so co-administration of an angiotensin II receptor antagonist tends to reverse the Potassium loss associated with these diuretics.
DosageView
Hypertension-
- The usual starting dose of 50/12.5 is one tablet once daily.
- For patients who do not respond adequately to one tablet the dosage may be increased to 100/25 once daily.
- A patient whose blood pressure is not adequately controlled with Losartan 100 mg monotherapy may be switched to this combination 100/12.5 once daily.
- In hypertensive patients with left ventricular hypertrophy initial dose is 50/12.5, if additional blood pressure reduction is needed, 100/12.5 may be given, followed by 100/25 if required. The maximum dose is 100/25 once daily.
- In general, the antihypertensive effect is attained within three weeks after initiation of therapy.
- No initial dosage adjustment of 50/12.5 is necessary for elderly patients. But maximum dose of 100/25 once daily dose should not be used as initial therapy in elderly patients.
- The starting dose for initial treatment of severe hypertension is one tablet of 50/12.5 once daily.
- For patients who do not respond adequately to this dose after 2 to 4 weeks of therapy, the dosage may be increased to 100/25 once daily. The maximum dose is one tablet of 100/25 once daily.
AdministrationView
This preparation may be administered with other antihypertensive agents. This may be administered with or without food.
Side effectsView
Side-effects are usually mild. Symptomatic hypotension including dizziness may occur, particularly in patients with intravascular volume depletion (e.g. those taking high-dose diuretics). Hyperkalaemia occurs occasionally; angioedema has also been reported with some angiotensin-II receptor antagonists. Vertigo; less commonly gastro-intestinal disturbances, angina, palpitation, oedema, dyspnoea, headache, sleep disorders, malaise, urticaria, pruritus, rash; rarely hepatitis, atrial fibrillation, cerebrovascular accident, syncope, paraesthesia; also reported pancreatitis, anaphylaxis, cough, depression, erectile dysfunction, anaemia, thrombocytopenia, hyponatraemia, arthralgia, myalgia, renal impairment, rhabdomyolysis, tinnitus, photosensitivity, and vasculitis (including Henoch-Schonlein purpura)
ContraindicationsView
The combination of Losartan and Hydrochlorothiazide is contraindicated in patients who are hypersensitive to any component of this product. Because of the Hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.
PrecautionsView
- Hypersensitivity: Angiooedema
- Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals
- Hypokalemia may rarely develop, especially with brisk diuresis, when severe cirrhosis is present, or after prolonged therapy
- Impaired renal function and
- Symptomatic hypotension
InteractionsView
Losartan Potassium: No significant drug-drug pharmacokinetic interactions have been found in interaction studies with Hydrochlorothiazide, Digoxin, Warfarin, Cimetidine and Phenobarbital. As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics (e.g. Spironolactone, Triamterene, Amiloride), potassium supplements, or salt substitutes containing potassium may lead to increase in serum potassium. As with other antihypertensive agents, the antihypertensive effect of Losartan may be blunted by the non-steroidal anti-inflammatory drug Indomethacin.
Hydrochlorothiazide: When administered concurrently, the following drugs may interact with Thiazide diuretics: alcohol, barbiturates, or narcotics-potentiation of orthostatic hypotension may occur.
Antidiabetic drugs (oral agents and Insulin): dosage adjustment of the antidiabetic drug may be required.
Other antihypertensive drugs: additive effect or potentiation.
Cholestyramine and colestipol resins: absorption of Hydrochlorothiazide is impaired in the presence of anionic exchange resins
Hydrochlorothiazide: When administered concurrently, the following drugs may interact with Thiazide diuretics: alcohol, barbiturates, or narcotics-potentiation of orthostatic hypotension may occur.
Antidiabetic drugs (oral agents and Insulin): dosage adjustment of the antidiabetic drug may be required.
Other antihypertensive drugs: additive effect or potentiation.
Cholestyramine and colestipol resins: absorption of Hydrochlorothiazide is impaired in the presence of anionic exchange resins
Pregnancy & lactationView
Angiotensin-II receptor antagonists should be avoided in pregnancy unless essential. They may adversely affect fetal and neonatal blood pressure control and renal function; skull defects and oligohy dramnios have also been reported. Information on the use of angiotensin-II receptor antagonists in breastfeeding is limited. They are not recommended in breastfeeding and alternative treatment options, with better-established safety information during breastfeeding, are available.
Pediatric usageView
Use in Patients with Renal Impairment: The usual regimens of therapy with 50/12.5 may be followed as long as the patient's creatinine clearance is >30 ml/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides. In that case, hydrochlorothiazide is not recommended.
Use in Patients with Hepatic Impairment: The combination of Losartan and Hydrochlorothiazide is not recommended for titration in patients with hepatic impairment because the appropriate 25 mg starting dose of Losartan cannot be given.
Use in pediatric patients: The safety and effectiveness in pediatric patients have not been established.
Use in Patients with Hepatic Impairment: The combination of Losartan and Hydrochlorothiazide is not recommended for titration in patients with hepatic impairment because the appropriate 25 mg starting dose of Losartan cannot be given.
Use in pediatric patients: The safety and effectiveness in pediatric patients have not been established.
Overdose effectsView
Losartan Potassium: Limited data are available in regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Neither losartan nor its metabolite can be removed by hemodialysis.
Hydrochlorothiazide: The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia, may accentuate cardiac arrhythmias. The degree to which Hydrochlorothiazide is removed by hemodialysis has not been established.
Hydrochlorothiazide: The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia, may accentuate cardiac arrhythmias. The degree to which Hydrochlorothiazide is removed by hemodialysis has not been established.
StorageView
Do not store above 30°C. Keep out of the reach of children.
Proscan
Flutamide
Proscan
Flutamide
Indications
Prostate carcinoma
Indication detailsView
Flutamide is indicated for use in combination with LHRH agonists for the management of locally confined Stage B2-C and Stage D2 metastatic carcinoma of the prostate.
Stage B2-C Prostatic Carcinoma: Treatment with Flutamide and the LHRH agonist should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy.
Stage D2 Metastatic Carcinoma: To achieve benefit from treatment, Flutamide should be initiated with the LHRH agonist and continued until progression.
Stage B2-C Prostatic Carcinoma: Treatment with Flutamide and the LHRH agonist should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy.
Stage D2 Metastatic Carcinoma: To achieve benefit from treatment, Flutamide should be initiated with the LHRH agonist and continued until progression.
Therapeutic classView
Hormonal Chemotherapy
PharmacologyView
Flutamide is a nonsteroidal 'pure' antiandrogen which acts directly on the target tissues either by blocking androgen uptake or by inhibiting cytoplasmic and nuclear binding of androgen.
DosageView
Oral (Adult)-
Palliative treatment of prostatic carcinoma: 250 mg tid preferably at least 3 days before gonadorelin analogue treatment. May be taken with or without food.
Palliative treatment of prostatic carcinoma: 250 mg tid preferably at least 3 days before gonadorelin analogue treatment. May be taken with or without food.
Side effectsView
Hot flushes, loss of libido, impotence, gynaecomastia, nausea, vomiting, diarrhoea, increased appetite, sleep disturbances, skin reactions, anaemias, headache, dizziness, malaise, anxiety, hypertension, gastric and chest pain, oedema, blurred vision, hepatitis, jaundice, rash, thirst, pruritus, SLE-like syndrome, drowsiness, confusion, depression, nervousness.
ContraindicationsView
Hypersensitivity, severe hepatic impairment, pregnancy and lactation.
PrecautionsView
Perform liver function tests before starting treatment and at regular intervals. Treatment is not recommended in patients whose ALT values exceed twice the upper limit of normal. Regular assessment of prostate specific antigen level may help to monitor disease progression. Advise patient against discontinuing drug on their own. Exercise caution in patients with cardiac disease.
InteractionsView
Increased prothrombin time in patients on long-term warfarin treatment.
Pregnancy & lactationView
Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
StorageView
Store at 25° C.
Prosectil
Omeprazole
Prosectil
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.
Prosectil
Omeprazole
Prosectil
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.
Prosfin
Finasteride [For B.P.H.]
Prosfin
Finasteride [For B.P.H.]
Indications
Supports normal prostate function
Indication detailsView
Finasteride is indicated for the treatment and control of benign prostatic hyperplasia (BPH)-
- To cause regression of the enlarged prostate
- To improve urinary flow
- To improve the symptoms associated with BPH.
Therapeutic classView
BPH/ Urinary retention/ Urinary incontinence
PharmacologyView
Finasteride, a competitive inhibitor of the 5α reductase enzyme which is used in the treatment of benign prostatic hyperplasia. It is selective for 5α reductase type 2 enzyme and has no affinity for androgen receptors. The development of the prostate gland and subsequent BPH is dependent upon conversion of testosterone to dihydrotestosterone (DHT) within the prostate. Finasteride belongs to a new class of specific inhibitors of 5α reductase, an intracellular enzyme, which metabolises testosterone into the more potent androgen, DHT. Finasteride has no affinity for the androgen receptor.
DosageView
The recommended dosage is one 5 mg tablet daily. Although early improvement may be seen, treatment for at least six months may be necessary to assess whether a beneficial response has been achieved. Thereafter, treatment should be continued.
Side effectsView
Finasteride is well tolerated. In clinical studies, the following adverse experiences have been reported as possibly drug related in 1% of patients treated for 12 months with 5 mg Finasteride daily: impotence (3.7%), decreased libido (3.3%), and decreased volume of ejaculate (2.8%).
ContraindicationsView
Hypersensitivity to any component of this medication. Finasteride use is also contraindicated in women and paediatric patient
PrecautionsView
General: Since the beneficial response to Finasteride may not be manifested immediately, patients with large residual urine volume and/or severely diminished urinary flow should be carefully monitored for obstructive uropathy.
Prostate cancer: Digital rectal examination, as well as, other evaluations for prostate cancer, should be performed on patients with BPH prior to initiating therapy with Finasteride and periodically thereafter. Finasteride causes a decrease in serum concentration of markers of prostatic cancer such as prostate specific antigen (PSA); therefore, reduction of serum levels of these markers in patients with BPH treated with Finasteride does not rule out concomitant prostate cancer. No clinical benefit has yet been demonstrated in patients with prostate cancer treated with Finasteride.
Prostate cancer: Digital rectal examination, as well as, other evaluations for prostate cancer, should be performed on patients with BPH prior to initiating therapy with Finasteride and periodically thereafter. Finasteride causes a decrease in serum concentration of markers of prostatic cancer such as prostate specific antigen (PSA); therefore, reduction of serum levels of these markers in patients with BPH treated with Finasteride does not rule out concomitant prostate cancer. No clinical benefit has yet been demonstrated in patients with prostate cancer treated with Finasteride.
InteractionsView
No clinically important drug interactions have been identified. Finasteride does not appear to significantly affect the cytochrome P450 linked drug metabolising enzyme system. Compounds which have been tested in man include Propranolol, Digoxin, Glibenclamide, Warfarin, Theophylline, and antipyrine.
Pregnancy & lactationView
Finasteride is contraindicated in women who are or may become pregnant. Finasteride is not indicated for use in women. It is not known whether finasteride is excreted in human milk.
Exposure to finasteride-risk to male fetus: Crushed or broken Finasteride Tablets should not be handled by women who are or may become pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus. Similarly, small amounts of finasteride have been recovered from the semen in subjects receiving Finasteride 5 mg/day. It is not known whether a male fetus may be adversely affected if his mother is exposed to the semen of a patient being treated with finasteride. Therefore, when the patients sexual partner is or may become pregnant, the patient should either avoid exposure of his partner to semen (e.g. by use of a condom) or discontinue Finasteride
Exposure to finasteride-risk to male fetus: Crushed or broken Finasteride Tablets should not be handled by women who are or may become pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus. Similarly, small amounts of finasteride have been recovered from the semen in subjects receiving Finasteride 5 mg/day. It is not known whether a male fetus may be adversely affected if his mother is exposed to the semen of a patient being treated with finasteride. Therefore, when the patients sexual partner is or may become pregnant, the patient should either avoid exposure of his partner to semen (e.g. by use of a condom) or discontinue Finasteride
Pediatric usageView
Renal insufficiency: Dosage adjustments are not necessary in patients with renal insufficiency since pharmacokinetic studies did not indicate any change in the disposition of Finasteride.
Hepatic insufficiency: There are no data available in patients with hepatic insufficiency.
Elderly: No dosage adjustment is required in elderly patients.
Hepatic insufficiency: There are no data available in patients with hepatic insufficiency.
Elderly: No dosage adjustment is required in elderly patients.
StorageView
Store at cool and dry place (below 30°C). Protect from light and moisture. Keep all the medicines out of the reach of children.
Prosma
Ketotifen Fumarate (Ophthalmic)
Prosma
Ketotifen Fumarate (Ophthalmic)
Indications
Watery eye
Indication detailsView
Ketotifen eye drop is indicated for the treatment of signs & symptoms (itchy, watery, red & swollen eyes and eyelids) of allergic conjunctivitis including vernal kerato-conjunctivitis, vernal-keratitis, blepharitis, blepharo-conjunctivitis, and giant papillary conjunctivitis.
Therapeutic classView
Ophthalmic Non-Steroid drugs
PharmacologyView
Ketotifen is a potent anti-allergic substance possessing a powerful and sustained non-competitive histamine (H1) receptor blocking property. Ketotifen inhibits the release of mediators (e.g histamine, leukotrienes and prostaglandins) from cells responsible for type-(I) allergic reactions. Ketotifen also stabilizes mast cells, decreases chemotaxis, activation of degranulation of eosinophils.
DosageView
Adults and children 3 years and older: 1 drop in the affected eye(s) twice daily, every 8-12 hours, not more than twice per day.
Children under 3 years of age: Consult with a doctor.
Children under 3 years of age: Consult with a doctor.
Side effectsView
Common side effects are burning, stinging, punctate corneal epithelial erosion, Blurring of vision upon drug instillation, dry eyes, eyelid disorder, conjunctivitis, eye pain, photophobia, subconjunctival haemorrhage.
ContraindicationsView
Hypersensitivity to Ketotifen or any of the components
PrecautionsView
The formulation of Ketotifen 0.025% eye drops contains benzalkonium chloride as a preservative, which may be deposited in soft contact lenses; therefore this eye drops should not be instilled while the patient is wearing lenses. The lenses should be removed before application of the drops and not reinserted earlier than 15 minutes after use.
InteractionsView
If Ketotifen eye drops is used concomitantly with other eye medications there must be an interval of at least 5 minutes between the two medications.
Pregnancy & lactationView
There are no adequate data from the use of ketotifen eye drops in pregnant women. Systemic levels after ocular administration are much lower than after oral use. Caution should be exercised when prescribing to pregnant women. Although animal data following oral administration show excretion into breast milk, topical administration to humans is unlikely to produce detectable quantities in breast milk. ketotifen 0.25% eye drops can be used during lactation.
Overdose effectsView
No case of overdose has been reported. Oral ingestion of the contents of a 5 ml bottle would be equivalent to 1.25 mg of Ketotifen which is 60% of a recommended oral daily dose for a 3 years old child. Clinical results have shown no serious signs or symptoms after oral ingestion of up to 20 mg of Ketotifen.
StorageView
Store in a cool and dry place protected from light and moisture. Keep out of reach of children. Do not touch the dropper tip to any surface since this may contaminate the solution. Do not use after 30 days of first opening.
Prosma
Ketotifen Fumarate (Oral)
Prosma
Ketotifen Fumarate (Oral)
Indications
Asthma prophylaxis
Indication detailsView
Ketotifen is indicated in the following conditions-
- For the prophylactic treatment of bronchial asthma.
- Symptomatic treatment of allergic conditions including rhinitis and conjunctivitis.
- For alleviating the complications of itching, pain and tenderness associated with neurofibroma.
- Symptomatic treatment of allergy such as hayfever, urticaria.
Therapeutic classView
Cromoglycate & related drugs
PharmacologyView
Ketotifen has anti-allergic properties and has been used similarly, to sodium chromoglycate in the prophylactic treatment of asthma. It also has the properties of an antihistamine. Ketotifen possesses marked anti-anaphylactic properties and is effective in preventing an asthmatic attacks. Ketotifen exerts as sustained inhibitory effect on histamine reactions, which can be clearly dissociated from its anti-anaphylactic properties. Experimental investigations in asthmatic subjects have shown that Ketotifen is as effective orally as a selective mast cell stabilizer administered by inhalation. Antihistamines were ineffective in those tests. The effectiveness of Ketotifen has been studied in long-term clinical trials. Asthma attacks were reduced in number, severity and duration and in some cases, the patients were completely freed from attacks. Progressive reduction of corticosteroids and/or bronchodilators was also possible. The prophylactic activity of Ketotifen may take several weeks to become fully established. Ketotifen will not abort established attacks of asthma.
DosageView
Adults: 1 mg twice daily with food. If necessary the dose may be increased to 2 mg twice daily in severe cases.
Children above 3 years: 1 mg twice daily with food. Patients known to be easily sedated should begin treatment with 0.5 to 1 mg at night for the first few days or as directed by the physician.
Use in elderly: Same as adult dose or as advised by the physician.
Children above 3 years: 1 mg twice daily with food. Patients known to be easily sedated should begin treatment with 0.5 to 1 mg at night for the first few days or as directed by the physician.
Use in elderly: Same as adult dose or as advised by the physician.
Side effectsView
Drowsiness and in isolated cases, dry mouth and slight dizziness may occur at the beginning of treatment but usually disappear spontaneously after a few days.
ContraindicationsView
A reversible fall in the platelet count has been observed in a few patients receiving Ketotifen concomitantly with oral antidiabetic agent and it has been suggested that this combination should therefore be avoided. Although there is no evidence of any teratogenic effect, recommendations for Ketotifen in pregnancy or when breast feeding can not be given.
PrecautionsView
It is important to continue the previous treatment for a minimum of two weeks after starting Ketotifen to avoid the possibility of exacerbation of asthma. This applies specially to systemic corticosteroids and ACTH because of the possible existence of adrenocortical insufficiency in steroid dependent patient. If inter current infection occurs, Ketotifen treatment must be supplemented by specific antimicrobial therapy. During the first day of treatment with Ketotifen, reactions may be impaired and patients should be warned not to take charge of vehicle or machinery until the effect of Ketotifen treatment on the individual is known. Patients should be advised to avoid alcoholic drinks. Ketotifen may potentiate the effects of sedatives, hypnotics, antihistamines and alcohol.
InteractionsView
Ketotifen may potentiate the effects of sedatives, hypnotics, antihistamines and alcohols. A reversible fall in the platelet count has been observed in a few patients receiving Tifen concomitantly with oral antidiabetic agents and it has been suggested that this combination should therefore be avoided.
Pregnancy & lactationView
Although there is no evidence of any teratogenic effect, Ketotifen in pregnancy and lactation is not recommended.
Overdose effectsView
The reported features of overdosage include confusion, drowsiness, headache, bradycardia, respiratory depression etc. should be watched for. Elimination of the drug with gastric lavage or emessis is recommended. Otherwise, general supportive treatment is all that is required shall be instituted.
StorageView
Store in a cool and dry place, protect from light. Keep out of the reach of children.
Prosma
Ketotifen Fumarate (Oral)
Prosma
Ketotifen Fumarate (Oral)
Indications
Asthma prophylaxis
Indication detailsView
Ketotifen is indicated in the following conditions-
- For the prophylactic treatment of bronchial asthma.
- Symptomatic treatment of allergic conditions including rhinitis and conjunctivitis.
- For alleviating the complications of itching, pain and tenderness associated with neurofibroma.
- Symptomatic treatment of allergy such as hayfever, urticaria.
Therapeutic classView
Cromoglycate & related drugs
PharmacologyView
Ketotifen has anti-allergic properties and has been used similarly, to sodium chromoglycate in the prophylactic treatment of asthma. It also has the properties of an antihistamine. Ketotifen possesses marked anti-anaphylactic properties and is effective in preventing an asthmatic attacks. Ketotifen exerts as sustained inhibitory effect on histamine reactions, which can be clearly dissociated from its anti-anaphylactic properties. Experimental investigations in asthmatic subjects have shown that Ketotifen is as effective orally as a selective mast cell stabilizer administered by inhalation. Antihistamines were ineffective in those tests. The effectiveness of Ketotifen has been studied in long-term clinical trials. Asthma attacks were reduced in number, severity and duration and in some cases, the patients were completely freed from attacks. Progressive reduction of corticosteroids and/or bronchodilators was also possible. The prophylactic activity of Ketotifen may take several weeks to become fully established. Ketotifen will not abort established attacks of asthma.
DosageView
Adults: 1 mg twice daily with food. If necessary the dose may be increased to 2 mg twice daily in severe cases.
Children above 3 years: 1 mg twice daily with food. Patients known to be easily sedated should begin treatment with 0.5 to 1 mg at night for the first few days or as directed by the physician.
Use in elderly: Same as adult dose or as advised by the physician.
Children above 3 years: 1 mg twice daily with food. Patients known to be easily sedated should begin treatment with 0.5 to 1 mg at night for the first few days or as directed by the physician.
Use in elderly: Same as adult dose or as advised by the physician.
Side effectsView
Drowsiness and in isolated cases, dry mouth and slight dizziness may occur at the beginning of treatment but usually disappear spontaneously after a few days.
ContraindicationsView
A reversible fall in the platelet count has been observed in a few patients receiving Ketotifen concomitantly with oral antidiabetic agent and it has been suggested that this combination should therefore be avoided. Although there is no evidence of any teratogenic effect, recommendations for Ketotifen in pregnancy or when breast feeding can not be given.
PrecautionsView
It is important to continue the previous treatment for a minimum of two weeks after starting Ketotifen to avoid the possibility of exacerbation of asthma. This applies specially to systemic corticosteroids and ACTH because of the possible existence of adrenocortical insufficiency in steroid dependent patient. If inter current infection occurs, Ketotifen treatment must be supplemented by specific antimicrobial therapy. During the first day of treatment with Ketotifen, reactions may be impaired and patients should be warned not to take charge of vehicle or machinery until the effect of Ketotifen treatment on the individual is known. Patients should be advised to avoid alcoholic drinks. Ketotifen may potentiate the effects of sedatives, hypnotics, antihistamines and alcohol.
InteractionsView
Ketotifen may potentiate the effects of sedatives, hypnotics, antihistamines and alcohols. A reversible fall in the platelet count has been observed in a few patients receiving Tifen concomitantly with oral antidiabetic agents and it has been suggested that this combination should therefore be avoided.
Pregnancy & lactationView
Although there is no evidence of any teratogenic effect, Ketotifen in pregnancy and lactation is not recommended.
Overdose effectsView
The reported features of overdosage include confusion, drowsiness, headache, bradycardia, respiratory depression etc. should be watched for. Elimination of the drug with gastric lavage or emessis is recommended. Otherwise, general supportive treatment is all that is required shall be instituted.
StorageView
Store in a cool and dry place, protect from light. Keep out of the reach of children.