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Benzodiazepine sedatives

Bromazepam is a powerful psychotropic agent. In lower dosage, it selectively reduces tension and anxiety. In higher dosage, it shows sedative and muscle-relaxant properties. Bromazepam binds to the GABA-A receptor producing a conformational change and potentiating its inhibitory effects. Other neurotransmitters are not influenced.

Standard dosage: Average dosage for outpatient therapy is 1.5-3 mg up to three times daily. Treatment of outpatients should begin with low doses, gradually increasing to the optimum level.

In severe cases, especially in hospital: 6-12 mg 2 or 3 times daily. The overall treatment generally should not be more than 8-12 weeks. In certain cases extension beyond the maximum treatment period may be necessary; if so, it should be taken with re-evaluation of the patient's status with special expertise.

Elderly and debilitated patients: Elderly patients and those with impaired hepatic functions require lower doses.

Children: Bromazepam is usually not indicated in children, but if the physician feels bromazepam treatment is appropriate, then the dose should be adjusted to their low bodyweight (about 0.1-0.3 mg/kg bodyweight)

Bromazepam tablets are for oral administration

Common side-effects include fatigue, drowsiness, muscle weakness, numbed muscle, reduced alertness, confusion, headache, ataxia etc. These phenomena occur predominantly at the start of therapy and usually disappear with prolonged administration. Anterograde amnesia may occur using therapeutic doses.

Bromazepam is contraindicated in patients with known hypersensitivity to bromazepam, severe respiratory insufficiency, severe hepatic insufficiency or sleep apnea syndrome.

The use of benzodiazepines and benzodiazepine like agents may lead to the development of physical and psychological dependence upon these products. This dependence depends on the dose and duration of treatment; it is also greater in predisposed patients with a history of alcohol. Once physical dependence has developed, termination of the treatment will be accompanied by withdrawal symptoms. These may consist of headache, muscle pain, extreme anxiety, tension, confusion and irritability. Since the risk of withdrawal phenomena and rebound phenomena is greater after abrupt discontinuation of the treatment, it is recommended that the dosage be decreased gradually. Bromazepam is not recommended for the primary treatment of sleeplessness caused by psychotic illness. Caution should be exercised while driving cars or using machineries.

If bromazepam is combined with other centrally active drugs, its sedative effects may be enhanced. These drugs are antidepressants, hypnotics, narcotics, antipsychotics, sedatives, antiepileptic drugs, sedative antihistamines and anesthetics. Co-administration of cimetidine may prolong the eliminiation half-life of bromazepam. Concomitant intake of bromazepam with alcohol should be avoided, because the sedative effect of bromazepam may be intensified by alcohol.

The safety of bromazepam during pregnancy has not been established. As bromazepam is excreted in breast milk, use should be avoided during lactation.

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

Lurasidone Hydrochloride is an atypical antipsychotic. This is used for the treatment of: Schizophrenia, Depressive episodes associated with Bipolar I Disorder (bipolar depression), as monotherapy and as adjunctive therapy with lithium or valproate.

Atypical neuroleptic drugs

The efficacy of Lurasidone in schizophrenia could be mediated through a combination of central Dopamine D2 and Serotonin 5HT2A receptor antagonism.

Schizophrenia-

• Starting Dose: 40 mg once daily
• Recommended Dose: 40 mg to 160 mg once daily

Bipolar Depression-

• Starting Dose: 20 mg once daily
• Recommended Dose: 20 mg to 120 mg once daily

Lurasidone  should be taken with food. Administration with food substantially increases the absorption of Lurasidone.

Somnolence, akathisia, extrapyramidal symptoms, and nausea.

Hypersensitivity. Concurrent administration of strong CYP3A4 inhibitors (eg, Ketoconazole). Concurrent administration of strong CYP3A4 inducers (eg, Rifampin). Dementia-related psychosis.

Cerebrovascular adverse reactions in elderly patients with dementia-related psychosis: Increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack).

Neuroleptic malignant syndrome: Manage with immediate discontinuation and close monitoring.

Tardive dyskinesia: Discontinue if clinically appropriate.

Metabolic changes: Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and weight gain.

Hyperglycemia and diabetes mellitus: Monitor patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Monitor glucose regularly in patients with diabetes or at risk for diabetes.

Dyslipidemia: Undesirable alterations have been observed in patients treated with atypical antipsychotics.

Weight Gain: Gain in body weight has been observed. Monitor weight.

Hyperprolactinemia: Prolactin elevations may occur.

Leukopenia, neutropenia and agranulocytosis: Perform complete blood counts (CBC) in patients with a pre-existing low white blood cell count (WBC) or a history of leukopenia or neutropenia. Consider discontinuing Lurasidone if a clinically significant decline in WBC occurs in the absence of other causative factors.

Orthostatic hypotension and syncope: Dizziness, tachycardia or bradycardia, and syncope may occur, especially early in treatment. In patients with known cardiovascularor cerebrovascular disease, and in antipsychotic-naïve patients, consider a lower starting dose and slower titration.

The Lurasidone dose should be reduced to half of the original level when used concomitantly with moderate inhibitors of CYP3A4 (e.g., Diltiazem, Atazanavir, Erythromycin, Fluconazole, Verapamil, etc.). If Lurasidone is used concomitantly with a moderate CYP3A4 inducer, it may be necessary to increase the Lurasidone dose.

Grapefruit: Grapefruit and grapefruit juice should be avoided in patients taking Lurasidone, since these may inhibit CYP3A4 and alter Lurasidone concentrations.

Pregnancy Category B. Lurasidone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Patient should be advised not to breast-feed an infant if they are taking Lurasidone.

Moderate and Severe Renal Impairment: Recommended starting dose is 20 mg per day, and the maximum recommended dose is 80 mg per day .

Moderate and Severe Hepatic Impairment: Recommended starting dose is 20 mg per day. The maximum recommended dose is 80 mg per day in moderate hepatic impairment and 40 mg per day in severe hepatic impairment.

Protect from light and moisture, store below 30° C. Keep out of the reach of children.

Lurasidone Hydrochloride is an atypical antipsychotic. This is used for the treatment of: Schizophrenia, Depressive episodes associated with Bipolar I Disorder (bipolar depression), as monotherapy and as adjunctive therapy with lithium or valproate.

Atypical neuroleptic drugs

The efficacy of Lurasidone in schizophrenia could be mediated through a combination of central Dopamine D2 and Serotonin 5HT2A receptor antagonism.

Schizophrenia-

• Starting Dose: 40 mg once daily
• Recommended Dose: 40 mg to 160 mg once daily

Bipolar Depression-

• Starting Dose: 20 mg once daily
• Recommended Dose: 20 mg to 120 mg once daily

Lurasidone  should be taken with food. Administration with food substantially increases the absorption of Lurasidone.

Somnolence, akathisia, extrapyramidal symptoms, and nausea.

Hypersensitivity. Concurrent administration of strong CYP3A4 inhibitors (eg, Ketoconazole). Concurrent administration of strong CYP3A4 inducers (eg, Rifampin). Dementia-related psychosis.

Cerebrovascular adverse reactions in elderly patients with dementia-related psychosis: Increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack).

Neuroleptic malignant syndrome: Manage with immediate discontinuation and close monitoring.

Tardive dyskinesia: Discontinue if clinically appropriate.

Metabolic changes: Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and weight gain.

Hyperglycemia and diabetes mellitus: Monitor patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Monitor glucose regularly in patients with diabetes or at risk for diabetes.

Dyslipidemia: Undesirable alterations have been observed in patients treated with atypical antipsychotics.

Weight Gain: Gain in body weight has been observed. Monitor weight.

Hyperprolactinemia: Prolactin elevations may occur.

Leukopenia, neutropenia and agranulocytosis: Perform complete blood counts (CBC) in patients with a pre-existing low white blood cell count (WBC) or a history of leukopenia or neutropenia. Consider discontinuing Lurasidone if a clinically significant decline in WBC occurs in the absence of other causative factors.

Orthostatic hypotension and syncope: Dizziness, tachycardia or bradycardia, and syncope may occur, especially early in treatment. In patients with known cardiovascularor cerebrovascular disease, and in antipsychotic-naïve patients, consider a lower starting dose and slower titration.

The Lurasidone dose should be reduced to half of the original level when used concomitantly with moderate inhibitors of CYP3A4 (e.g., Diltiazem, Atazanavir, Erythromycin, Fluconazole, Verapamil, etc.). If Lurasidone is used concomitantly with a moderate CYP3A4 inducer, it may be necessary to increase the Lurasidone dose.

Grapefruit: Grapefruit and grapefruit juice should be avoided in patients taking Lurasidone, since these may inhibit CYP3A4 and alter Lurasidone concentrations.

Pregnancy Category B. Lurasidone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Patient should be advised not to breast-feed an infant if they are taking Lurasidone.

Moderate and Severe Renal Impairment: Recommended starting dose is 20 mg per day, and the maximum recommended dose is 80 mg per day .

Moderate and Severe Hepatic Impairment: Recommended starting dose is 20 mg per day. The maximum recommended dose is 80 mg per day in moderate hepatic impairment and 40 mg per day in severe hepatic impairment.

Protect from light and moisture, store below 30° C. Keep out of the reach of children.

Osmotic purgatives

Lactulose is a synthetic disaccharide. Lactulose is metabolized in the colon by the saccharolytic bacteria, producing low molecular weight organic acids (mainly lactic acid), which lowers the pH of the colon contents, promote the retention of water by an osmotic effect; thus increasing peristaltic activity. Lactulose is minimally absorbed; therefore, the pharmacokinetics of the absorbed material are not relevant to the principal therapeutic action.

In constipation ( chronic constipation):

• Adults: Initially 3-6 tea-spoons daily, In long-term therapy 1½-6 tea-spoons daily
• Children up to 14 years: Initially 3 tea-spoons daily, In long-term therapy 1-2 tea-spoons daily
• Infants and toddlers: Initially 1-2 tea-spoons daily, In long-term therapy 1 tea-spoon daily

In damaged intestinal flora:

• Adults: 1-2 tea-spoons daily
• Children: 1 tea-spoon daily

For reduction of blood ammonia level:

• Hyper-ammoniemia in hepatopathy: a maximum of 18-30 tea-spoons daily.
• In portal systemic encephalopathy: hourly doses of 6-9 tea-spoons of Lactulose solution may be used to induce the rapid laxation. When the laxative effect has been achieved, the dose may then be reduced.

Occasionally flatulence, cramp and abdominal discomfort can occur at the beginning of treatment; this is rapidly eliminated by reducing the dose. Overdose can result in diarrhoea. In abuse, loss of electrolytes (primarily potassium).

Hypersensitivity to either galactose and or lactose; galactose-free diet, gastro-cardial symptom complex, suspected intestinal obstruction.

Lactulose should be administered with care to patients who are intolerant to lactulose. The dose used in the treatment of (pre) coma hepaticum is usually much higher and may need to be taken into consideration for diabetics.

There is no significant drug interactions with lactulose. The glycosidic effect of cardiac glycosides can be intensified by potassium deficiency in abuse.

US FDA Pregnancy Category of Lactulose is B. Studies show that Lactulose has no adverse effects. Decisions regarding use during pregnancy and lactation must be made by registered physician.

There have been no reports of accidental overdosage. In the event of acute overdosage it is expected that diarrhoea and abdominal cramps would be the major symptoms.

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

Psyllium Husk is indicated in-

• Constipation
• Raised levels of cholesterol
• Hemorrhoids or piles
• Irritable bowel syndrome (IBS)
• Reduces blood glucose level

Psyllium also provides easy bowel movement with smooth stool. So, it is desirable in patients with anal fissures, colon cancer, post anal & rectal surgery and during pregnancy.

Bulk-forming laxatives

Usual dose: 1 spoonful 1-3 times daily or as per doctor's advice.

Adults and children over 12 years: 1 spoonful with water 2 times daily or as per doctor's advice.

Children 6 to 12 years: ½ to 1 spoonful with water depending on age and size, in the morning and at bedtime or as per doctor's advice.

Children below 6 years: Not recommended except as directed by the physician.

An additional glass of water is helpful after taking this gel.

Common side effects are flatulence, abdominal distension, gastro-intestinal obstruction.

Contraindicated in patients with gastrointestinal tract obstruction or threatening obstruction of the bowel.

No significant interaction has been observed with other medicine.

Store in a cool and dry place. Keep out of reach of children.

Psyllium Husk is indicated in-

• Constipation
• Raised levels of cholesterol
• Hemorrhoids or piles
• Irritable bowel syndrome (IBS)
• Reduces blood glucose level

Psyllium also provides easy bowel movement with smooth stool. So, it is desirable in patients with anal fissures, colon cancer, post anal & rectal surgery and during pregnancy.

Bulk-forming laxatives

Usual dose: 1 spoonful 1-3 times daily or as per doctor's advice.

Adults and children over 12 years: 1 spoonful with water 2 times daily or as per doctor's advice.

Children 6 to 12 years: ½ to 1 spoonful with water depending on age and size, in the morning and at bedtime or as per doctor's advice.

Children below 6 years: Not recommended except as directed by the physician.

An additional glass of water is helpful after taking this gel.

Common side effects are flatulence, abdominal distension, gastro-intestinal obstruction.

Contraindicated in patients with gastrointestinal tract obstruction or threatening obstruction of the bowel.

No significant interaction has been observed with other medicine.

Store in a cool and dry place. Keep out of reach of children.

Psyllium fiber and standardized Senna extract is indicated in-

• Constipation
• Hemorrhoids or piles
• Bowel regulation for bed ridden patient

Bulk-forming laxatives, Herbal and Nutraceuticals

Psyllium Fiber & Senna Extract has documented laxative effect for Psyllium or Ispaghula husk powder (Plantago ovata) and standardized Senna extract (Cassia angustifolia). When one spoonful of powder is mixed with water it forms an orange colored and flavored drink. Psyllium (bulk-forming laxative) contains mucilage and Senna extract (stimulant laxative) contains hydroxyanthracene glycosides (as Sennoside B) that helps to relieve constipation and normalizes bowel action. The additive effect of Psyllium Fiber & Senna Extract is ensured for its combination partners. This special combination preparation accelerates intestinal passage and increases water absorption to increase filling pressure. Psyllium Fiber & Senna Extract helps to reduce pain by easy bowel evacuation with soft stool for patients who are suffering from haemorrhoids (piles), rectal surgery and colon cancer. It has soothing effects on gastric and intestinal mucosa, gastric irritation and ulceration. Psyllium Fiber & Senna Extract helps to maintain serum cholesterol and blood glucose level.

Adults and children over 12 years old: 1-2 spoonful at night with at least 150 ml water or as directed by physician. Intake of additional water will be helpful. This can be taken with fruit juice, milk and warm drink. And should not be taken until ½ to 1 hour after intake of other medications. Continuous use for more than 2 weeks requires medical supervision.

Occasionally allergic reaction may occur. Chronic use may cause loss of electrolytes (potassium) that will reverse upon discontinuation.

Contraindicated for patients with pathological narrowing in gastrointestinal tract, intestinal obstructions, difficult-to-control diabetes mellitus, acutely inflamed intestinal diseases, e.g. Crohn's disease, ulcerative colitis, appendicitis and abdominal pain of unknown origin. Contraindicated for children under 12 years old.

Drink immediately after preparation. Keep tightly closed after each use.

Chronic use may causes potassium deficiency which may increase the effectiveness of cardiac glycosides and may influence the action of antiarrhythmic drugs. Potassium deficiency can be increased by simultaneous application of thiazide diuretics, corticoadrenal steroids. A reduction of dose of insulin may be necessary for insulin dependent diabetic patients. The absorption of concurrently administered drugs can be delayed.

Recommended but special precaution should be taken during first trimester of pregnancy.

Overdose may alter electrolyte and water balance.

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

Psyllium Husk is indicated in-

• Constipation
• Raised levels of cholesterol
• Hemorrhoids or piles
• Irritable bowel syndrome (IBS)
• Reduces blood glucose level

Psyllium also provides easy bowel movement with smooth stool. So, it is desirable in patients with anal fissures, colon cancer, post anal & rectal surgery and during pregnancy.

Bulk-forming laxatives

Usual dose: 1 spoonful 1-3 times daily or as per doctor's advice.

Adults and children over 12 years: 1 spoonful with water 2 times daily or as per doctor's advice.

Children 6 to 12 years: ½ to 1 spoonful with water depending on age and size, in the morning and at bedtime or as per doctor's advice.

Children below 6 years: Not recommended except as directed by the physician.

An additional glass of water is helpful after taking this gel.

Common side effects are flatulence, abdominal distension, gastro-intestinal obstruction.

Contraindicated in patients with gastrointestinal tract obstruction or threatening obstruction of the bowel.

No significant interaction has been observed with other medicine.

Store in a cool and dry place. Keep out of reach of children.

Osmotic purgatives

Lactulose is a synthetic disaccharide. Lactulose is metabolized in the colon by the saccharolytic bacteria, producing low molecular weight organic acids (mainly lactic acid), which lowers the pH of the colon contents, promote the retention of water by an osmotic effect; thus increasing peristaltic activity. Lactulose is minimally absorbed; therefore, the pharmacokinetics of the absorbed material are not relevant to the principal therapeutic action.

In constipation ( chronic constipation):

• Adults: Initially 3-6 tea-spoons daily, In long-term therapy 1½-6 tea-spoons daily
• Children up to 14 years: Initially 3 tea-spoons daily, In long-term therapy 1-2 tea-spoons daily
• Infants and toddlers: Initially 1-2 tea-spoons daily, In long-term therapy 1 tea-spoon daily

In damaged intestinal flora:

• Adults: 1-2 tea-spoons daily
• Children: 1 tea-spoon daily

For reduction of blood ammonia level:

• Hyper-ammoniemia in hepatopathy: a maximum of 18-30 tea-spoons daily.
• In portal systemic encephalopathy: hourly doses of 6-9 tea-spoons of Lactulose solution may be used to induce the rapid laxation. When the laxative effect has been achieved, the dose may then be reduced.

Occasionally flatulence, cramp and abdominal discomfort can occur at the beginning of treatment; this is rapidly eliminated by reducing the dose. Overdose can result in diarrhoea. In abuse, loss of electrolytes (primarily potassium).

Hypersensitivity to either galactose and or lactose; galactose-free diet, gastro-cardial symptom complex, suspected intestinal obstruction.

Lactulose should be administered with care to patients who are intolerant to lactulose. The dose used in the treatment of (pre) coma hepaticum is usually much higher and may need to be taken into consideration for diabetics.

There is no significant drug interactions with lactulose. The glycosidic effect of cardiac glycosides can be intensified by potassium deficiency in abuse.

US FDA Pregnancy Category of Lactulose is B. Studies show that Lactulose has no adverse effects. Decisions regarding use during pregnancy and lactation must be made by registered physician.

There have been no reports of accidental overdosage. In the event of acute overdosage it is expected that diarrhoea and abdominal cramps would be the major symptoms.

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

This preparation is indicated in-

• Constipation
• Hyperacidity with constipation
• Anorectal disorder
• Post-operative constipation
• Constipation associated with chronic cholecystitis
• Hernia

Antacid with laxative action

This preparation has a dual-relief formulation containing a gentle laxative ingredient and a lubricant which eases the discomfort associated with straining and bowel movement. It is recommended for the temporary relief of constipation

The recommended oral dose are as follows-
Adults: 15-30ml before breakfast or at bedtime.

Children:

• Over 7 years: 7.5 ml-15 ml at bedtime.
• 3-7 years: 5-10 ml at bedtime.

The dose may be mixed with milk or half a glass of water if desired. Don't take for more than 1 week unless under doctor's supervision

Rectal irritation, potassium loss (thirst, weakness, nausea and diarrhea).

Acute Gl conditions like abdominal pain.

Renal and hepatic impairment. Maintain adequate fluid intake.

Cimetidine, Diuretics, Famotidine and Ranitidine may cause irritation of stomach or bowel.

Can be given to pregnant and lactating mother.

There are no reported cases of overdosage.

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

It is used to treat hard stools (constipation).

Osmotic purgatives

Senna glycoside, also known as sennoside or senna, is a medication used to treat constipation and empty the large intestine before surgery. The medication is taken by mouth or via the rectum. It typically begins working in minutes when given by rectum and within twelve hours when given by mouth. It is a weaker laxative than bisacodyl or castor oil.

Sennosides A and B increase intestinal motility through release of active anthraquinones into the colon by colonic bacteria. Purified sennosides (sennosides A and B) are used similarly to senna.

Constipation

• Adult: 15-30 mg (as total sennosides) 1-2 times daily.
• Child: 2-6 yr: 3.75-7.5 mg once daily in the morning; 6-12 yr: 7.5-15 mg once daily at night or in the morning; ≥12 yr: 15-30 mg at bedtime.

Bowel evacuation

• Adult: 105-157.5 mg of sennosides on the day before the procedure. May be given as a liquid preparation.

Mild abdominal discomfort e.g. colic and cramps; diarrhoea, hypokalaemia and atonic non-functioning colon (prolonged use); reversible melanosis coli (chronic use). May colour the urine yellowish-brown at acidic pH or red at alkaline pH.

Nausea or vomiting, undiagnosed abdominal pain, intestinal obstruction.

Inflammatory bowel disease. Avoid prolonged use.

Sennosides has been assigned to pregnancy category C by the FDA. Animal studies have failed to reveal evidence of teratogenicity. There are no controlled data in human pregnancy. Sennosides should only be given during pregnancy when benefits outweigh risks.

Sennosides is not excreted into human milk. However, Sennosides is a prodrug which is metabolized in vivo to the active sennosides (glucosides of rhein). Rhein is excreted into human milk in very small amounts. No adverse effects have been observed in nursing infants. The American Academy of Pediatrics considers Sennosides to be compatible with breast-feeding.

Psyllium Husk is indicated in-

• Constipation
• Raised levels of cholesterol
• Hemorrhoids or piles
• Irritable bowel syndrome (IBS)
• Reduces blood glucose level

Psyllium also provides easy bowel movement with smooth stool. So, it is desirable in patients with anal fissures, colon cancer, post anal & rectal surgery and during pregnancy.

Bulk-forming laxatives

Usual dose: 1 spoonful 1-3 times daily or as per doctor's advice.

Adults and children over 12 years: 1 spoonful with water 2 times daily or as per doctor's advice.

Children 6 to 12 years: ½ to 1 spoonful with water depending on age and size, in the morning and at bedtime or as per doctor's advice.

Children below 6 years: Not recommended except as directed by the physician.

An additional glass of water is helpful after taking this gel.

Common side effects are flatulence, abdominal distension, gastro-intestinal obstruction.

Contraindicated in patients with gastrointestinal tract obstruction or threatening obstruction of the bowel.

No significant interaction has been observed with other medicine.

Store in a cool and dry place. Keep out of reach of children.

Frusemide & Spironolactone combination is indicated in-

• Essential hypertension
• Chronic congestive heart failure
• Hepatic cirrhosis, with collection of fluid in the abdominal cavity (ascites)
• Swelling due to excess fluid retention (edema)
• Hyperaldosteronism
• Resistant edema associated with secondary hyperaldosteronism

Potassium-sparing diuretics, Potassium-sparing diuretics & Aldosterone antagonists

Spironolactone (potassium sparing diuretic) and Furosemide (loop diuretic) have different but complementary mechanisms and sites of action. Therefore, when given together they produce additive or synergistic diuretic. The Furosemide component inhibits the Na+/K+/2Cl- co-transporter in the ascending Loop of Henle and blocks the reabsorption of sodium, potassium and chloride ions; thereby increasing the quantity of sodium and the volume of water excreted in the urine. This characteristically induces potassium loss. The spironolactone component inhibits the reabsorption of sodium in exchange for potassium at the distal tubule by antagonising the action of aldosterone so that sodium excretion is greatly favoured and the excess loss of potassium, induced by the Furosemide, is reduced

Furosemide 20 and spironolactone 50 mg: 1 to 4 tablets daily (20 to 80 mg of Furosemide and 50 to 200 mg of spironolactone) according to the patient’s response.

Furosemide 40 and spironolactone 50 mg: For previously stabilized patients requiring a higher dosage of spironolactone and Furosemide, This tablet can be used at a dose of one to two tablets daily (Furosemide 40 to 80 mg and spironolactone 50 to 100 mg).

Use in children: Spironolactone and Furosemide is not suitable for use in children. Spironolactone and Furosemide may both be excreted more slowly in the elderly.

Spironolactone may give rise to headache and drowsiness and gastrointestinal distress, including cramp and diarrhoea. Ataxia, mental confusion, and skin rashes have been reported as side effect. Gynaecomastia is not uncommon and in rare cases breast enlargement may persist. Other endocrine disorders including hirsutism, deepening of the voice, menstrual irregularities and impotence. Transient increase in blood-urea-nitrogen concentrations may occur and mild acidosis has been reported. Spironolactone may cause hyponatremia and hyperkalemia. Excessive diuresis may result in dehydration and reduction in blood volume with circulatory collapse with the possibility of vascular thrombosis and embolism particularly in elderly patients. Serious depletion of potassium and magnesium may lead to cardiac arrhythmias.

Contraindicated in patients with anuria, acute renal insufficiency, rapidly deteriorating or severe impairment of renal function (creatinine clearance <30 ml/min), hyperkalaemia, Addison's disease and in patients who are hypersensitive to Spironolactone, Furosemide or sulphonamides.

Caution should be taken in patients liable to electrolyte deficiency. This preparation should also be used with caution in diabetes, enlarged prostate, hypotension and in hypovolemia.

When taken together with ACE inhibitors or potassium salts there is an increased risk of hyperkalemia. Spironolactone increases the levels of cardiac glycosides such as digoxin in the blood and this may result in digitalis toxicity. Corticosteroids may cause hypokalemia if they are used with Spironolactone. The blood pressure lowering and diuretic effects of Furosemide may be reduced or abolished when used together with indomethacin and possibly other non-steroidal anti-inflammatory drugs (NSAIDs). Furosemide may increase the ototoxicity of aminoglycoside antibiotics. Simultaneous administration of sucralfate and Furosemide may reduce the natriuretic and anti-hypertensive effect of Furosemide.

Pregnancy: Spironolactone and its metabolites may cross the placental barrier. The use of spironolactone in pregnant women requires that the anticipated benefit be weighed against the possible hazards to the mother and fetus. Animal teratology studies indicate that Furosemide may cause fetal abnormalities. Therefore, Furosemide should only be used in women in child bearing age when appropriate contraceptive measures are taken or if the potential benefits justify the potential risks to the fetus.

Lactation: Metabolites of Spironolactone have been detected in breast milk. If use of Spironolactone is considered essential, an alternative method of infant feeding should be instituted. Furosemide is excreted in breast milk and breast-feeding should be discontinued if treatment is essential.

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

Lactitol Monohydrate is indicated in chronic idiopathic constipation (CIC), acute and chronic portal systemic encephalopathy.

Osmotic purgatives

Lactitol Monohydrate is a disaccharide derivatives consisting of galactose and sorbitol, which is only minimally absorbed and is not hydrolysed by the disaccharidases of the GIT and thus reaches the colon unchanged. In the colon it is broken down to short chain low molecular weight organic acids by the intestinal flora, resulting in an increase in osmotic pressure in the colon, thereby causing an increase in the stool water content and stool volume, which explains the laxative effect. Lactitol Monohydrate produces its effect in the lumen of the colon, where it is virtually 100% bioavailable. It is absorbed only in minimal amounts. Up to 2% can be found unchanged in the urine.

Lactitol can be mixed with hot or cold beverages, puddings etc. Dosage will require adjustment to obtaine one daily bowel movement in constipated patients and two daily bowel movements in patients with portal systemic encephalopathy.

In constipation: In adult: The initial daily dosage should be 20 g taken in a single dose with the morning or evening meal. After a few days, a daily dose of 10 g may be sufficient.

Children: The mean dosage is 0.25 g/kg body weight daily.

• 1 to 6 years: 2.5 to 5 gm
• 6 to 12 years: 5 to 10 gm
• 12 to 16 years: 10 to 20 gm

The effect of lactitol has been found mostly to occur within a few hours after intake. But in some cases the first laxative response may be delayed until the second or third day of administration. Therefore patients should be advised to maintain an adequate daily fluid intake.

In portal systemic encephalopathy: The dose should be adjusted according to the severity of the patient’s disease and their individual response. The initial recommended dose is 0.5 to 0.7 gm/kg body weight daily, divided into three daily doses with meals.

At the start of the treatment with lactitol may produce abdominal discomforts such as flatulence, pain, cramps or sensation of fullness. Such effects tend to diminish or disappear after a few days of regular intake of Lactitol. Occasionally, nausea or anal pruritus has been reported in some cases.

Patients with known hypersensitivity to any of the ingredients of this preparation.

Antacids and neomycin should not be given simultaneously with Lactitol to cirrhotic patients with portal systemic encephalopathy. Lactitol may increase potassium loss caused by other drugs e.g. thiazide diuretics, corticosteroids, carbenoxolone, amphotericin B and it may enhance the risk of toxic effects of glycosides in patients receiving concomitant therapy.

Lactitol is minimally absorbed systemically following oral administration, and it is unknown whether maternal use will result in fetal exposure to the drug. There are no data on the presence of lactitol in human or animal milk, the effects on the breastfed infant, or the effects on milk production.

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

Lactitol Monohydrate is indicated in chronic idiopathic constipation (CIC), acute and chronic portal systemic encephalopathy.

Osmotic purgatives

Lactitol Monohydrate is a disaccharide derivatives consisting of galactose and sorbitol, which is only minimally absorbed and is not hydrolysed by the disaccharidases of the GIT and thus reaches the colon unchanged. In the colon it is broken down to short chain low molecular weight organic acids by the intestinal flora, resulting in an increase in osmotic pressure in the colon, thereby causing an increase in the stool water content and stool volume, which explains the laxative effect. Lactitol Monohydrate produces its effect in the lumen of the colon, where it is virtually 100% bioavailable. It is absorbed only in minimal amounts. Up to 2% can be found unchanged in the urine.

Lactitol can be mixed with hot or cold beverages, puddings etc. Dosage will require adjustment to obtaine one daily bowel movement in constipated patients and two daily bowel movements in patients with portal systemic encephalopathy.

In constipation: In adult: The initial daily dosage should be 20 g taken in a single dose with the morning or evening meal. After a few days, a daily dose of 10 g may be sufficient.

Children: The mean dosage is 0.25 g/kg body weight daily.

• 1 to 6 years: 2.5 to 5 gm
• 6 to 12 years: 5 to 10 gm
• 12 to 16 years: 10 to 20 gm

The effect of lactitol has been found mostly to occur within a few hours after intake. But in some cases the first laxative response may be delayed until the second or third day of administration. Therefore patients should be advised to maintain an adequate daily fluid intake.

In portal systemic encephalopathy: The dose should be adjusted according to the severity of the patient’s disease and their individual response. The initial recommended dose is 0.5 to 0.7 gm/kg body weight daily, divided into three daily doses with meals.

At the start of the treatment with lactitol may produce abdominal discomforts such as flatulence, pain, cramps or sensation of fullness. Such effects tend to diminish or disappear after a few days of regular intake of Lactitol. Occasionally, nausea or anal pruritus has been reported in some cases.

Patients with known hypersensitivity to any of the ingredients of this preparation.

Antacids and neomycin should not be given simultaneously with Lactitol to cirrhotic patients with portal systemic encephalopathy. Lactitol may increase potassium loss caused by other drugs e.g. thiazide diuretics, corticosteroids, carbenoxolone, amphotericin B and it may enhance the risk of toxic effects of glycosides in patients receiving concomitant therapy.

Lactitol is minimally absorbed systemically following oral administration, and it is unknown whether maternal use will result in fetal exposure to the drug. There are no data on the presence of lactitol in human or animal milk, the effects on the breastfed infant, or the effects on milk production.

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

4-Quinolone preparations

Levofloxacin is a synthetic, broad-spectrum, third generation fluoroquinolone antibiotic. Chemically, Levofloxacin is a chiral fluorinated carboxyquinolone. Levofloxacin exerts antibacterial action by inhibiting bacterial topoisomerase IV and DNA gyrase, the enzymes required for DNA replication, transcription repair and recombination. It has in vitro activity against a wide range of gm-ve and gm+ve microorganisms.

The usual dose of Levofloxacin Tablets is 250 mg or 500 mg or 750 mg administered orally every 24 hours. Levofloxacin tablets can be administered without regard to food. Levofloxacin oral solution should be taken 1 hour before, or  2 hours after eating.

Levofloxacin injection should only be administered by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration. The usual dose of Levofloxacin injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours. Since the Levofloxacin injections are for single-use only, any unused portion should be discarded. Additives or other medications should not be added to Levofloxacin Injection or infused simultaneously through the same intravenous line.

Adults:

• Acute sinusitis: 500 mg once daily for 10-14 days, or 750 mg once daily for 5 days
• Exacerbation of chronic bronchitis: 500 mg once daily for 7 days, or 750 mg once daily for 3 days (Uncomplicated), 750 mg once daily for 5 days (Complicated)
• Community-acquired pneumonia: 500 mg once daily for 7-14 days, or 750 mg once daily for 5 days
• Uncomplicated urinary-tract infections: 250 mg once daily for 3 days
• Complicated urinary-tract infections and acute pyelonephritis: 250 mg once daily for 7-10 days
• Uncomplicated skin and soft-tissue infections: 500 mg once daily for 7-10 days.
• Complicated skin and soft-tissue infections: 750 mg once daily for 7-14 days.
• Enteric fever: 500 mg once daily for 7-14 days.
• Diarrhea, cholera, shigellosis & enteritis: Mild to moderate case: 500 mg (single dose). Moderate to sever case: 500 mg once daily for 3 days

Children:

• Children 6 months to <5 years: 10 mg/kg every 12 hours.
• Children >5 years: 10 mg/kg every 24 hours

In each case, sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.

Instructions for the Use of Levofloxacin Infusion-

• Check the container for minute leaks by squeezing the inner bag firmly. If leaks are found, or if the seal is not intact, discard the solution.
• Do not use if the solution is cloudy or a precipitate is present.
• Do not use flexible containers in series connections.
• Close flow control clamp of administration set.
• Remove cover from port at bottom of container.
• Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
• Suspend container from hanger.
• Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Levoxin Injection.
• Open flow control clamp to expel air from set. Close clamp.
• Regulate rate of administration with flow control clamp.

Levofloxacin is generally well tolerated. However, a few side-effects can usually be seen. There is a risk of retinal detachment. Other side-effects include: nausea, vomiting, diarrhea, abdominal pain, flatulence and rare occurrence of phototoxicity (0.1%). Side-effects that may be seen very rarely include tremors, depression, anxiety, confusion etc.

Levofloxacin is contraindicated in patients with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents, or any other components of this product.

The following measures should be taken during administration of Levofloxacin:

• Levofloxacin Injection should only be administered by slow intravenous infusion over a period of 60 or 90 minutes depending on the dosage.
• While administrating Levofloxacin, adequate amount of water should be taken to avoid concentrated form of urine.
• Dose adjustment should be exercised during Levofloxacin administration in presence of renal insufficiency.

No quinolone should be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line. Antacids, Iron and Adsorbents reduce absorption of Levofloxacin. NSAID may increase the risk of CNS stimulation. Warfarin may increase the risk of bleeding.

Levofloxacin is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.

Levofloxacin exhibits a low potential for acute toxicity. However, in the events of an acute overdosage, the stomach should be emptied. The patients should be kept under observation and appropriate hydration should be maintained.

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

For use in adults and children over 12 years of age for effective relief from constipation and treatment of chronic constipation. Also effective in resolving faecal impaction, defined as refractory constipation with faecal loading of the rectum and colon.

Osmotic purgatives

Macrogol (3350) exerts an osmotic action in the gut, which induces a laxative effect. Macrogol (3350) increases the stool volume, which triggers colon motility via neuromuscular pathways. The physiological consequence is an improved propulsive colonic transportation of the soften stools and a facilitation of the defecation. Electrolytes combined with Macrogol (3350) are exchanged across the intestinal barrier (mucosa) with serum electrolytes and excreted without net gain or loss of sodium, potassium and water. Macrogol (3350) is unchanged along the gut. It is virtually unabsorbed from the gastrointestinal tract.

Measure 25 ml of this oral solution with the measuring cup provided, then add this to 100 ml of water. Any unused diluted solution should be discarded within 24 hours.

Adult:

• Constipation: 25 ml of this oral solution added to 100 ml of water once daily (to make a total volume of 125 ml). This may be increased to 2 - 3 doses of 25 ml daily (each 25 ml dose added to 100 ml of water), if required according to individual response.
• Fecal Impaction: 8 doses of 25 ml daily (each 25 ml dose added to 100 ml of water). A course of treatment for fecal impaction does not normally exceed 3 days.

Children (12-18 years): 25 ml of this oral solution added to 100 ml of water once daily.

In the treatment of chronic constipation, diarrhoea or loose stools normally respond to a reduction in dose. Diarrhoea, abdominal distension, anorectal discomfort and mild vomiting are more often observed during the treatment for fecal impaction. Vomiting may be resolved if the dose is reduced or delayed.

Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, ileus, severe inflammatory conditions of the intestinal tract, such as Crohn's disease and ulcerative colitis and toxic megacolon. Hypersensitivity to the active substances.

This medicinal product contains 8.125 mmol of sodium in each dose of 125 ml. The sodium content of this oral solution should be taken into consideration when administering the product to patients on a controlled sodium diet.

There is a possibility that the absorption of other medicinal products could be transiently reduced during use with this oral solution. There have been isolated reports of decreased efficacy with some concomitantly administered medicinal products, e.g. anti-epileptics.

Clinically, no effects during pregnancy are anticipated, since systemic exposure to Macrogol (3350) is negligible. This oral solution can be used during pregnancy. No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to Macrogol (3350) is negligible. This oral solution can be used during breast-feeding.

Extensive fluid loss by diarrhea or vomiting may require correction of electrolyte disturbances.

Store below 30° C and in a place protected from light. Do not refrigerate.

Osmotic purgatives

Lactulose is a synthetic disaccharide. Lactulose is metabolized in the colon by the saccharolytic bacteria, producing low molecular weight organic acids (mainly lactic acid), which lowers the pH of the colon contents, promote the retention of water by an osmotic effect; thus increasing peristaltic activity. Lactulose is minimally absorbed; therefore, the pharmacokinetics of the absorbed material are not relevant to the principal therapeutic action.

In constipation ( chronic constipation):

• Adults: Initially 3-6 tea-spoons daily, In long-term therapy 1½-6 tea-spoons daily
• Children up to 14 years: Initially 3 tea-spoons daily, In long-term therapy 1-2 tea-spoons daily
• Infants and toddlers: Initially 1-2 tea-spoons daily, In long-term therapy 1 tea-spoon daily

In damaged intestinal flora:

• Adults: 1-2 tea-spoons daily
• Children: 1 tea-spoon daily

For reduction of blood ammonia level:

• Hyper-ammoniemia in hepatopathy: a maximum of 18-30 tea-spoons daily.
• In portal systemic encephalopathy: hourly doses of 6-9 tea-spoons of Lactulose solution may be used to induce the rapid laxation. When the laxative effect has been achieved, the dose may then be reduced.

Occasionally flatulence, cramp and abdominal discomfort can occur at the beginning of treatment; this is rapidly eliminated by reducing the dose. Overdose can result in diarrhoea. In abuse, loss of electrolytes (primarily potassium).

Hypersensitivity to either galactose and or lactose; galactose-free diet, gastro-cardial symptom complex, suspected intestinal obstruction.

Lactulose should be administered with care to patients who are intolerant to lactulose. The dose used in the treatment of (pre) coma hepaticum is usually much higher and may need to be taken into consideration for diabetics.

There is no significant drug interactions with lactulose. The glycosidic effect of cardiac glycosides can be intensified by potassium deficiency in abuse.

US FDA Pregnancy Category of Lactulose is B. Studies show that Lactulose has no adverse effects. Decisions regarding use during pregnancy and lactation must be made by registered physician.

There have been no reports of accidental overdosage. In the event of acute overdosage it is expected that diarrhoea and abdominal cramps would be the major symptoms.

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

Osmotic purgatives

Lactulose is a synthetic disaccharide. Lactulose is metabolized in the colon by the saccharolytic bacteria, producing low molecular weight organic acids (mainly lactic acid), which lowers the pH of the colon contents, promote the retention of water by an osmotic effect; thus increasing peristaltic activity. Lactulose is minimally absorbed; therefore, the pharmacokinetics of the absorbed material are not relevant to the principal therapeutic action.

In constipation ( chronic constipation):

• Adults: Initially 3-6 tea-spoons daily, In long-term therapy 1½-6 tea-spoons daily
• Children up to 14 years: Initially 3 tea-spoons daily, In long-term therapy 1-2 tea-spoons daily
• Infants and toddlers: Initially 1-2 tea-spoons daily, In long-term therapy 1 tea-spoon daily

In damaged intestinal flora:

• Adults: 1-2 tea-spoons daily
• Children: 1 tea-spoon daily

For reduction of blood ammonia level:

• Hyper-ammoniemia in hepatopathy: a maximum of 18-30 tea-spoons daily.
• In portal systemic encephalopathy: hourly doses of 6-9 tea-spoons of Lactulose solution may be used to induce the rapid laxation. When the laxative effect has been achieved, the dose may then be reduced.

Occasionally flatulence, cramp and abdominal discomfort can occur at the beginning of treatment; this is rapidly eliminated by reducing the dose. Overdose can result in diarrhoea. In abuse, loss of electrolytes (primarily potassium).

Hypersensitivity to either galactose and or lactose; galactose-free diet, gastro-cardial symptom complex, suspected intestinal obstruction.

Lactulose should be administered with care to patients who are intolerant to lactulose. The dose used in the treatment of (pre) coma hepaticum is usually much higher and may need to be taken into consideration for diabetics.

There is no significant drug interactions with lactulose. The glycosidic effect of cardiac glycosides can be intensified by potassium deficiency in abuse.

US FDA Pregnancy Category of Lactulose is B. Studies show that Lactulose has no adverse effects. Decisions regarding use during pregnancy and lactation must be made by registered physician.

There have been no reports of accidental overdosage. In the event of acute overdosage it is expected that diarrhoea and abdominal cramps would be the major symptoms.

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

Benzodiazepine sedatives

Bromazepam is a powerful psychotropic agent. In lower dosage, it selectively reduces tension and anxiety. In higher dosage, it shows sedative and muscle-relaxant properties. Bromazepam binds to the GABA-A receptor producing a conformational change and potentiating its inhibitory effects. Other neurotransmitters are not influenced.

Standard dosage: Average dosage for outpatient therapy is 1.5-3 mg up to three times daily. Treatment of outpatients should begin with low doses, gradually increasing to the optimum level.

In severe cases, especially in hospital: 6-12 mg 2 or 3 times daily. The overall treatment generally should not be more than 8-12 weeks. In certain cases extension beyond the maximum treatment period may be necessary; if so, it should be taken with re-evaluation of the patient's status with special expertise.

Elderly and debilitated patients: Elderly patients and those with impaired hepatic functions require lower doses.

Children: Bromazepam is usually not indicated in children, but if the physician feels bromazepam treatment is appropriate, then the dose should be adjusted to their low bodyweight (about 0.1-0.3 mg/kg bodyweight)

Bromazepam tablets are for oral administration

Common side-effects include fatigue, drowsiness, muscle weakness, numbed muscle, reduced alertness, confusion, headache, ataxia etc. These phenomena occur predominantly at the start of therapy and usually disappear with prolonged administration. Anterograde amnesia may occur using therapeutic doses.

Bromazepam is contraindicated in patients with known hypersensitivity to bromazepam, severe respiratory insufficiency, severe hepatic insufficiency or sleep apnea syndrome.

The use of benzodiazepines and benzodiazepine like agents may lead to the development of physical and psychological dependence upon these products. This dependence depends on the dose and duration of treatment; it is also greater in predisposed patients with a history of alcohol. Once physical dependence has developed, termination of the treatment will be accompanied by withdrawal symptoms. These may consist of headache, muscle pain, extreme anxiety, tension, confusion and irritability. Since the risk of withdrawal phenomena and rebound phenomena is greater after abrupt discontinuation of the treatment, it is recommended that the dosage be decreased gradually. Bromazepam is not recommended for the primary treatment of sleeplessness caused by psychotic illness. Caution should be exercised while driving cars or using machineries.

If bromazepam is combined with other centrally active drugs, its sedative effects may be enhanced. These drugs are antidepressants, hypnotics, narcotics, antipsychotics, sedatives, antiepileptic drugs, sedative antihistamines and anesthetics. Co-administration of cimetidine may prolong the eliminiation half-life of bromazepam. Concomitant intake of bromazepam with alcohol should be avoided, because the sedative effect of bromazepam may be intensified by alcohol.

The safety of bromazepam during pregnancy has not been established. As bromazepam is excreted in breast milk, use should be avoided during lactation.

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