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Anti-oxidant Multivitamin preparations

Beta carotene of this tablet is converted to vitamin A (Retinol) when required. Retinol has several biochemical functions e.g. on retina, growth, tissue differentiation, immunological response. It has also some anti-cancer activity.

Vitamin C is the most powerful reducing agent known to be present in living tissues. Vitamin C deficiency produces scurvy. It is a cofactor in numerous biological processes. Vitamin C and molecular oxygen are essential for the conversion of proline to hydroxyproline, dopamine to noradrenaline . Vitamin C is also essential for the synthesis of adrenal steroid hormones. Vitamin C is important in the defense against infection and studies shown that vitamin C is important for the normal functioning of T-lymphocyte and leukocyte. Ascorbic acid has some antiinflammatory activity and protects cells against oxidation of essential molecules. In high doses, (1-2 g daily) ascorbic acid increases iron absorption.

vitamin E seems to be as a defense against oxidative stress and lipid peroxidation. In most cell membranes there is one molecule of tocopherol for every 1000 lipid molecules. Tocopherol mops up peroxide radicals and then needs a supply of reduced hydrogen to restore the steady-state situation. This is usually supplied by ascorbic acid or reduced glutathione.

This tablet is administered orally. The adult dose of this combination of antioxidant vitamin tablet is 1 tablet daily or as prescribed by the physician.

β carotene is comparatively safe even at high and prolonged exposure. Individuals who routinely ingest large amounts of carotenoids can develop hypercarotenosis, which is characterised by a yellowish colouration of the skin and a very high concentration of carotenoids in the plasma. This benign condition, although resembling jaundice, gradually disappears upon correcting the excessive intake of carotenoids.

Vitamin C is generally a safe drug for human use in normal doses. Larger doses may lead to gastrointestinal tract upset and renal stone formation.

Vitamin E is considered safe even in large doses. Doses over 800 mg may cause diarrhoea, abdominal pain or cramps, fatigue and reduced resistance to bacterial infection and transiently raised blood pressure.

Carocet is contraindicated in patients with hypersensitivity to any of its components.

There are some evidences that β carotene may cause harm to heavy smokers and alcoholics. Therefore, caution should be exercised in these cases. Vitamin C should be given with caution to patients with hyperoxaluria. Vitamin E should be used with caution in patients taking anticoagulant drugs, because vitamin E may enhance the anticoagulant activity of these drugs.

Cholestyramine, Colestipol, Neomycin cause decreased absorption of β carotene. Circulating vitamin C levels have been shown to be reduced during prolonged administration of oral contraceptives containing Oestrogen, Tetracycline and Aspirin. The decrease in vitamin C level may be due to drug induced impaired absorption or increased utilization of the vitamin for drug metabolism. Vitamin E may enhance the anticoagulant activity of anticoagulant drugs. High doses of vitamin E can impair intestinal absorption of vitamins A and K.

β carotene, vitamin C and vitamin E have no teratogenic effects in humans. However, like any other drugs caution should be taken in prescribing to pregnant women.

Should be stored in a dry place below 30˚C.

Tabkheer is indicated in-

• Gastroesophageal reflux disorders
• Flatulence
• Indigestion
• Hyperacidity

Herbal and Nutraceuticals

1-2 capsule(s) daily or as prescribed by the physician.

No significant side effect has been reported in therapeutic dosage.

There is no known contraindication.

Keep out of reach of the children.

Store in cool and dry place, protect from light.

Sildenafil is indicated for the treatment of erectile dysfunction.

Drugs for Erectile Dysfunction

Sildenafil is a selective inhibitor of cyclic Guanosine Monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5) used for treatment of erectile dysfunction. Danafil (Sildenafil) enhances the effect of nitric oxide (NO) by inhibiting phosphodiesterase type 5 (PDE5), which is responsible for degradation of cGMP in the corpus cavernosum that results in smooth muscle relaxation and inflow of blood to the corpus cavernosum.

The recommended dose of Sildenafil is 50 mg taken approximately 1 hour before sexual activity. However, Sildenafil may be taken anywhere from half an hour to 4 hours before sexual activity. Based on effectiveness and toleration, the dose may be increased to a maximum 100 mg or decreased to 25 mg. The maximum recommended dosing frequency is once per day.

Sildenafil may takes longer time to work if you take it with a heavy meal.

The adverse effects treated with Sildenafil are headache, flushing, dyspepsia, nasal congestion, urinary tract infection, abnormal vision, diarrhea, dizziness and rash.

Sildenafil is contraindicated in patient with hypersensitivity to any component of this medication. Sildenafil potentiates the hypotensive effects of nitrates, so it is contraindicated in patients who are using organic nitrates, either regularly or intermittently.

Caution should be exercised if patients have any allergies to any other medicines or any other substances such as foods, preservatives or dyes, heart or blood vessel problems, sudden loss of eyesight in one or both eyes. Caution should be taken if patients have any of the following medical conditions such as diabetes, kidney or liver problems, leukaemia, multiple myeloma, any disease or deformity of penis, any bleeding disorder such as haemophilia, stomach ulcer, sickle cell anaemia, color vision problems, sudden decrease or loss of hearing or receiving any other treatment for impotence.

Concomitant use of Sildenafil with organic nitrates for angina may cause hypotension. Cimetidine, a medicine used to treat gastric ulcers, some antibiotics including Erythromycin and Rifampicin, some protease inhibitors such as Ritonavir and Saquinavir for the treatment of HIV infection may increase the plasma concentration of Sildenafil. Some medicines used to treat fungal infections including Ketoconazole and Itraconazole may reduce the clearance of Sildenafil.

Pregnancy category B. There are no adequate and well-controlled studies of Sildenafil in pregnant women. Sildenafil is not indicated for use by women. In animal study shows that Sildenafil has no evidence of teratogenicity or embryotoxicity.

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

Sildenafil is indicated for the treatment of erectile dysfunction.

Drugs for Erectile Dysfunction

Sildenafil is a selective inhibitor of cyclic Guanosine Monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5) used for treatment of erectile dysfunction. Danafil (Sildenafil) enhances the effect of nitric oxide (NO) by inhibiting phosphodiesterase type 5 (PDE5), which is responsible for degradation of cGMP in the corpus cavernosum that results in smooth muscle relaxation and inflow of blood to the corpus cavernosum.

The recommended dose of Sildenafil is 50 mg taken approximately 1 hour before sexual activity. However, Sildenafil may be taken anywhere from half an hour to 4 hours before sexual activity. Based on effectiveness and toleration, the dose may be increased to a maximum 100 mg or decreased to 25 mg. The maximum recommended dosing frequency is once per day.

Sildenafil may takes longer time to work if you take it with a heavy meal.

The adverse effects treated with Sildenafil are headache, flushing, dyspepsia, nasal congestion, urinary tract infection, abnormal vision, diarrhea, dizziness and rash.

Sildenafil is contraindicated in patient with hypersensitivity to any component of this medication. Sildenafil potentiates the hypotensive effects of nitrates, so it is contraindicated in patients who are using organic nitrates, either regularly or intermittently.

Caution should be exercised if patients have any allergies to any other medicines or any other substances such as foods, preservatives or dyes, heart or blood vessel problems, sudden loss of eyesight in one or both eyes. Caution should be taken if patients have any of the following medical conditions such as diabetes, kidney or liver problems, leukaemia, multiple myeloma, any disease or deformity of penis, any bleeding disorder such as haemophilia, stomach ulcer, sickle cell anaemia, color vision problems, sudden decrease or loss of hearing or receiving any other treatment for impotence.

Concomitant use of Sildenafil with organic nitrates for angina may cause hypotension. Cimetidine, a medicine used to treat gastric ulcers, some antibiotics including Erythromycin and Rifampicin, some protease inhibitors such as Ritonavir and Saquinavir for the treatment of HIV infection may increase the plasma concentration of Sildenafil. Some medicines used to treat fungal infections including Ketoconazole and Itraconazole may reduce the clearance of Sildenafil.

Pregnancy category B. There are no adequate and well-controlled studies of Sildenafil in pregnant women. Sildenafil is not indicated for use by women. In animal study shows that Sildenafil has no evidence of teratogenicity or embryotoxicity.

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

This capsule is a combination antiplatelet agent indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or a complete ischemic stroke due to thrombosis.

Anti-platelet drugs

This is a combination of anti-platelet agents Aspirin & Dipyridamole intended for oral administration. Aspirin inhibits platelet aggregation by irreversible inhibition of platelet cyclooxygenase and thus inhibits the generation of thromboxane A2. Dipyridamole inhibits platelet aggregation by inhibiting the uptake of adenosine into platelet, which is a potent mediator of vasodilation. Dipyridamole increases local concentration of adenosine which increases cAMP (cyclic-adenosine monophosphate) level thus decreased ca⁺⁺ concentration and inhibits platelet aggregation. Dipyridamole also inhibits phosphodiesterase (PDE) especially cyclic-guanosine monophosphate-PDE (cGMP-PDE), which increases cGMP produced by EDRF (endothelium-derived relaxing factor) Nitric oxide a potent vasodilator.

The recommended dose is one capsule given orally twice daily. One in the morning and one in the evening. Capsules should be swallowed whole without chewing. This can be administered with or without food.

Pediatric Use: The safety and effectiveness of this capsule in pediatric patients have not been studied. So, the use of this preparation in the pediatric population is not recommended.

The most frequently reported adverse reactions are headache, dyspepsia, abdominal pain, nausea and diarrhea.

Hypersensitivity: This capsule is contraindicated in patients with known hypersensitivity to any of the product components.

Allergy: Aspirin is contraindicated in patients with known allergy to Nonsteroidal anti-inflammatory drugs and in patients with the syndrome of asthma, rhinitis and nasal polyps. Aspirin may cause severe urticaria, angioedema or bronchospasm.

Reye Syndrome: Aspirin should not be used in children or teenagers with viral infections because of the risk of Reye syndrome.

This is not interchangeable with the individual components of Aspirin and Dipyridamole tablets. This increases the risk of Intracranial Hemorrhage & Gastrointestinal Bleeding. Avoid this in patient with peptic ulcer, coronary artery diseases, hypotension & severe renal failure or hepatic insufficiency.

Co-administration with anticoagulants, antiplatelets or NSAIDS can increase risk of bleeding. Decreased renal function can occur with co-administration with NSAID, beta blockers and diuretics. Dipyridamole may counteract the anticholinesterase effect of cholinesterase inhibitors, thereby potentially aggravating myasthenia gravis.

Pregnancy Category D. Aspirin can results in excessive blood loss at delivery as well as prolonged gestation and prolonged labor. So this capsule should be avoided in the third trimester of pregnancy and during labor and delivery. Both Dipyridamole and Aspirin are excreted in human milk. This capsule not to be administered to a nursing woman.

Overdosage of this is likely to be dominated by signs and symptoms of Dipyridamole & Aspirin overdoses. Overdose of Dipyridamole shows hemodynamic effects with various symptoms such as warm feeling, flushes, sweating, restlessness, feeling of weakness, dizziness and a drop in blood pressure and tachycardia might also be observed. The sign of Aspirin overdose includes tinnitus, hyperthermia and hypovolemia. Treatment of overdose consists primarily of supporting vital functions, increasing drug elimination, correcting acid-base disturbances and gastric emptying or lavage as soon as possible after ingestion. Maintain fluid, electrolyte balance and to control the hypoglycemic condition intravenous fluid and infusion of glucose must be administered. Administration of Xanthine derivatives (e.g. aminophylline) may reverse the hemodynamic effects of Dipyridamole overdose.

Store at cool & dry place. Protect from light. Keep away from reach of children.

Alogliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type-2 diabetes mellitus.

Dipeptidyl Peptidase-4 (DPP-4) inhibitor

Alogliptin is a DPP-4 inhibitor that slows the inactivation of the incretin hormones, thereby increasing their bloodstream concentrations and reducing fasting and postprandial glucose concentrations in a glucose-dependent manner in patients with type 2 diabetes mellitus. Increased concentrations of the incretin hormones such as glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) are released into the bloodstream from the small intestine in response to meals. These hormones cause insulin release from the pancreatic beta cells in a glucose-dependent manner but are inactivated by the DPP-4 enzyme within minutes. GLP-1 also lowers glucagon secretion from pancreatic alpha cells, reducing hepatic glucose production. In patients with type 2 diabetes, concentrations of GLP-1 are reduced but the insulin response to GLP-1 is preserved.

The recommended dose in patients with normal renal function or mild renal impairment is 25 mg once daily or as directed by the physicians.

Common side effects are nasopharyngitis, headache and upper respiratory tract infection.

History of a serious hypersensitivity reaction to Alogliptin-containing products, such as anaphylaxis, angioedema or severe cutaneous adverse reactions.

Acute pancreatitis: If pancreatitis is suspected, promptly Alogliptin should be discontinued.

Hypersensitivity: There have been postmarketing reports of serious hypersensitivity reactions in patients treated with Alogliptin such as anaphylaxis, angioedema and severe cutaneous adverse reactions. In such cases, promptly Alogliptin should be discontinued.

Hepatic effects: Postmarketing reports of hepatic failure, sometimes fatal. Causality can not be excluded. If liver injury is detected, promptly interrupt Alogliptin and assess patient for probable cause, then treat cause if possible, to resolution or stabilization. Do not restart Alogliptin if liver injury is confirmed and no alternative etiology can be found.

Hypoglycemia: When an insulin secretagogue (e.g. sulfonylurea) or insulin is used in combination with Alogliptin, a lower dose of the insulin secretagogue or insulin may be required to minimize the risk of hypoglycaemia.

Macrovascular outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Alogliptin or any other antidiabetic drug.

Alogliptin is primarily renally excreted. Cytochrome (CYP) P450-related metabolism is negligible. No significant drug-drug interactions are observed with the CYP-substrates or inhibitors tested or with renally excreted drugs.

Pregnancy Category B. No adequate or well-controlled studies in pregnant women have been conducted with Alogliptin. Alogliptin tablets should be used during pregnancy only if clearly needed. It is not known whether Alogliptintin is excreted in human milk. caution should be exercised when Alogliptin is administered to a nursing woman.

Pediatric Use: Safety and effectiveness of Alogliptin in pediatric patients have not been established.

Geriatric Use: Of the total number of patients (N=8507) in clinical safety and efficacy studies treated with Alogliptin, 2064 (24.3%) patients were 65 years and older and 341 (4%) patients were 75 years and older. No overall differences in safety or effectiveness were observed between patients 65 years and over and younger patients. While this clinical experience has not identified differences in responses between the elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out.

Hepatic Impairment: No dose adjustments are required in patients with mild to moderate hepatic impairment (Child-Pugh Grade A and B) based on insignificant change in systemic exposures (e.g., AUC) compared to subjects with normal hepatic function in a pharmacokinetic study. Alogliptin has not been studied in patients with severe hepatic impairment (Child-Pugh Grade C). Use caution when administering Alogliptin to patients with liver disease.

Patients with Renal Impairment:

• No dose adjustment of Alogliptin is necessary for patients with mild renal impairment (creatinine clearance ≥60 mL/min).
• The dose of Alogliptin is 12.5 mg once daily for patients with moderate renal impairment (creatinine clearance ≥30 to <60 mL/min).
• The dose of Alogliptin is 6.25 mg once daily for patients with severe renal impairment (creatinine clearance ≥15 to <30 mL/min) or with end-stage renal disease (ESRD) (creatinine clearance <15 mL/min or requiring hemodialysis).
• Patients requiring hemodialysis can receive their dose of alogliptin without regard to the timing of the dialysis.

The highest doses of Alogliptin administered in clinical trials were single doses of 800 mg to healthy subjects and doses of 400 mg once daily for 14 days to patients with type 2 diabetes (equivalent to 32 times and 16 times the maximum recommended clinical dose of 25 mg, respectively). No serious adverse events were observed at these doses. In the event of an overdose, it is reasonable to institute the necessary clinical monitoring and supportive therapy as dictated by the patient's clinical status. Per clinical judgment, it may be reasonable to initiate removal of unabsorbed material from the gastrointestinal tract. Alogliptin is minimally dialyzable; over a 3-hour hemodialysis session, approximately 7% of the drug was removed. Therefore, hemodialysis is unlikely to be beneficial in an overdose situation. It is not known if Alogliptin is dialyzable by peritoneal dialysis.

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

Alogliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type-2 diabetes mellitus.

Dipeptidyl Peptidase-4 (DPP-4) inhibitor

Alogliptin is a DPP-4 inhibitor that slows the inactivation of the incretin hormones, thereby increasing their bloodstream concentrations and reducing fasting and postprandial glucose concentrations in a glucose-dependent manner in patients with type 2 diabetes mellitus. Increased concentrations of the incretin hormones such as glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) are released into the bloodstream from the small intestine in response to meals. These hormones cause insulin release from the pancreatic beta cells in a glucose-dependent manner but are inactivated by the DPP-4 enzyme within minutes. GLP-1 also lowers glucagon secretion from pancreatic alpha cells, reducing hepatic glucose production. In patients with type 2 diabetes, concentrations of GLP-1 are reduced but the insulin response to GLP-1 is preserved.

The recommended dose in patients with normal renal function or mild renal impairment is 25 mg once daily or as directed by the physicians.

Common side effects are nasopharyngitis, headache and upper respiratory tract infection.

History of a serious hypersensitivity reaction to Alogliptin-containing products, such as anaphylaxis, angioedema or severe cutaneous adverse reactions.

Acute pancreatitis: If pancreatitis is suspected, promptly Alogliptin should be discontinued.

Hypersensitivity: There have been postmarketing reports of serious hypersensitivity reactions in patients treated with Alogliptin such as anaphylaxis, angioedema and severe cutaneous adverse reactions. In such cases, promptly Alogliptin should be discontinued.

Hepatic effects: Postmarketing reports of hepatic failure, sometimes fatal. Causality can not be excluded. If liver injury is detected, promptly interrupt Alogliptin and assess patient for probable cause, then treat cause if possible, to resolution or stabilization. Do not restart Alogliptin if liver injury is confirmed and no alternative etiology can be found.

Hypoglycemia: When an insulin secretagogue (e.g. sulfonylurea) or insulin is used in combination with Alogliptin, a lower dose of the insulin secretagogue or insulin may be required to minimize the risk of hypoglycaemia.

Macrovascular outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Alogliptin or any other antidiabetic drug.

Alogliptin is primarily renally excreted. Cytochrome (CYP) P450-related metabolism is negligible. No significant drug-drug interactions are observed with the CYP-substrates or inhibitors tested or with renally excreted drugs.

Pregnancy Category B. No adequate or well-controlled studies in pregnant women have been conducted with Alogliptin. Alogliptin tablets should be used during pregnancy only if clearly needed. It is not known whether Alogliptintin is excreted in human milk. caution should be exercised when Alogliptin is administered to a nursing woman.

Pediatric Use: Safety and effectiveness of Alogliptin in pediatric patients have not been established.

Geriatric Use: Of the total number of patients (N=8507) in clinical safety and efficacy studies treated with Alogliptin, 2064 (24.3%) patients were 65 years and older and 341 (4%) patients were 75 years and older. No overall differences in safety or effectiveness were observed between patients 65 years and over and younger patients. While this clinical experience has not identified differences in responses between the elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out.

Hepatic Impairment: No dose adjustments are required in patients with mild to moderate hepatic impairment (Child-Pugh Grade A and B) based on insignificant change in systemic exposures (e.g., AUC) compared to subjects with normal hepatic function in a pharmacokinetic study. Alogliptin has not been studied in patients with severe hepatic impairment (Child-Pugh Grade C). Use caution when administering Alogliptin to patients with liver disease.

Patients with Renal Impairment:

• No dose adjustment of Alogliptin is necessary for patients with mild renal impairment (creatinine clearance ≥60 mL/min).
• The dose of Alogliptin is 12.5 mg once daily for patients with moderate renal impairment (creatinine clearance ≥30 to <60 mL/min).
• The dose of Alogliptin is 6.25 mg once daily for patients with severe renal impairment (creatinine clearance ≥15 to <30 mL/min) or with end-stage renal disease (ESRD) (creatinine clearance <15 mL/min or requiring hemodialysis).
• Patients requiring hemodialysis can receive their dose of alogliptin without regard to the timing of the dialysis.

The highest doses of Alogliptin administered in clinical trials were single doses of 800 mg to healthy subjects and doses of 400 mg once daily for 14 days to patients with type 2 diabetes (equivalent to 32 times and 16 times the maximum recommended clinical dose of 25 mg, respectively). No serious adverse events were observed at these doses. In the event of an overdose, it is reasonable to institute the necessary clinical monitoring and supportive therapy as dictated by the patient's clinical status. Per clinical judgment, it may be reasonable to initiate removal of unabsorbed material from the gastrointestinal tract. Alogliptin is minimally dialyzable; over a 3-hour hemodialysis session, approximately 7% of the drug was removed. Therefore, hemodialysis is unlikely to be beneficial in an overdose situation. It is not known if Alogliptin is dialyzable by peritoneal dialysis.

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

Agomelatine is indicated for:

• Major depressive disorder especially in non-responders and intolerant to SSRIs
• Generalized anxiety disorder
• Bipolar depression
• Sleep disturbances
• Seasonal affective disorder
• Migraine and cluster headaches

Atypical anti-depressant drugs

This compound binds to the melatoninergic receptors and the serotoninergic 5-HT2c receptor giving rise to the Melatonin Agonist and Selective Serotonin Antagonist (MASSA) concept. The melatoninergic receptors MT1 and MT2, are G protein coupled receptors and they act through decreasing cAMP and cGMP. Agomelatine strongly binds to and stimulates the activity of MT1 and MT2 receptors normalizing the disturbed circadian rhythms and disrupted sleep-wake cycles. Unlike the existing antidepressants, agomelatine does not inhibit the uptake of serotonin, norepinephrine or dopamine. It inhibits 5HT-2C receptor (G protein coupled receptor which increases IP3/DAG secondary messenger system) found abundantly in the SCN, frontal cortex, hippocampus and basal ganglia involved in the mood, motor and cognitive deficits associated with depressive states. 5HT-2C receptor antagonism increases norepinephrine and dopamine levels in the frontal cortex of the brain. This action of agomelatine produces antidepressant, antianxiety and also increases slow-wave sleep which is decreased in depression. It has been observed that it can increase neurogenesis in the hippocampus and may also have neuroprotective effects (by influencing glutamate release, glucocorticoid receptor gene expression and various neurotropic factors) which might also contribute to its antidepressant effects. A study has shown that agomelatine alleviates sleep disturbances after one week of therapy and by two weeks antidepressant effects manifest. The combined actions of agomelatine at MT1, MT2, and 5HT-2C receptors can improve the disturbed circadian rhythm and abnormal sleep pattern thus produce the antidepressant effect. These unique effects suggest that it might be effective for the treatment of seasonal affective disorder like anxiety and bipolar depression.

The effective dose of agomelatine is 25 mg per day given once at bed time for two weeks and can be increased to 50 mg per day in patients with inadequate response. Night time dosing is recommended because agomelatine improves the quality of sleep without day time sedation.

For oral administration with or without food. Most adult patients should take a dosage of 25 mg (one tablet) daily. It is usually taking prior to bed time. If no improvement is noticed after two weeks, the dosage can be increased to 50 mg (two tablets) daily.

The commonly reported adverse effects in the clinical trials of agomelatine are headache, nausea and diarrhea.

It is contraindicated in patients with hepatic impairment and hypersensitivity to the active substances or any of the excipients.

It is found to increase the level of liver enzymes and so monitoring of enzyme level is warranted before starting therapy and therefore every 6 weeks.

Potential interactions affecting agomelatine: Agomelatine is metabolised mainly by cytochrome P450 1A2 (CYP1A2) (90%) and by CYP2C9 (10%). Medicinal products that interact with these isoenzymes may decrease or increase the bioavailability of agomelatine. Fluvoxamine, a potent CYP1A2 and moderate CYP2C9 inhibitor markedly inhibits the metabolism of agomelatine resulting in a 60-fold (range 12-412) increase of agomelatine exposure. Consequently, co-administration of agomelatine with potent CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin) is contraindicated.

For agomelatine, no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see Toxicology: Preclinical Safety Data under Actions). Caution should be exercised when prescribing to pregnant women. It is not known whether Agomelatine is excreted into human milk. agomelatine or its metabolites are excreted in the milk of lactating rats. Potential effects of agomelatine on the breastfeeding infant have not been established. If treatment with agomelatine is considered necessary, breastfeeding should be discontinued.

Children under 18 years: Should be given only on medical advice.

Children and adolescents: Agomelatine is not recommended in the treatment of depression in patients .

Use in the elderly: Efficacy has not been clearly demonstrated in the elderly (65 years). Only limited clinical data is available on the use of Agomelatine in elderly patients 65 years with major depressive episodes. Therefore, caution should be exercised when prescribing Agomelatine to these patients.

There is limited experience with agomelatine overdose. During the clinical development, there were a few reports of agomelatine overdose, taken alone (up to 450 mg) or in combination (up to 525 mg) with other psychotropic medicinal products. Signs and symptoms of overdose were limited and included drowsiness and epigastralgia. No specific antidotes for agomelatine are known. Management of overdose should consist of treatment of clinical symptoms and routine monitoring. Medical follow-up in a specialised environment is recommended.

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

Agomelatine is indicated for:

• Major depressive disorder especially in non-responders and intolerant to SSRIs
• Generalized anxiety disorder
• Bipolar depression
• Sleep disturbances
• Seasonal affective disorder
• Migraine and cluster headaches

Atypical anti-depressant drugs

This compound binds to the melatoninergic receptors and the serotoninergic 5-HT2c receptor giving rise to the Melatonin Agonist and Selective Serotonin Antagonist (MASSA) concept. The melatoninergic receptors MT1 and MT2, are G protein coupled receptors and they act through decreasing cAMP and cGMP. Agomelatine strongly binds to and stimulates the activity of MT1 and MT2 receptors normalizing the disturbed circadian rhythms and disrupted sleep-wake cycles. Unlike the existing antidepressants, agomelatine does not inhibit the uptake of serotonin, norepinephrine or dopamine. It inhibits 5HT-2C receptor (G protein coupled receptor which increases IP3/DAG secondary messenger system) found abundantly in the SCN, frontal cortex, hippocampus and basal ganglia involved in the mood, motor and cognitive deficits associated with depressive states. 5HT-2C receptor antagonism increases norepinephrine and dopamine levels in the frontal cortex of the brain. This action of agomelatine produces antidepressant, antianxiety and also increases slow-wave sleep which is decreased in depression. It has been observed that it can increase neurogenesis in the hippocampus and may also have neuroprotective effects (by influencing glutamate release, glucocorticoid receptor gene expression and various neurotropic factors) which might also contribute to its antidepressant effects. A study has shown that agomelatine alleviates sleep disturbances after one week of therapy and by two weeks antidepressant effects manifest. The combined actions of agomelatine at MT1, MT2, and 5HT-2C receptors can improve the disturbed circadian rhythm and abnormal sleep pattern thus produce the antidepressant effect. These unique effects suggest that it might be effective for the treatment of seasonal affective disorder like anxiety and bipolar depression.

The effective dose of agomelatine is 25 mg per day given once at bed time for two weeks and can be increased to 50 mg per day in patients with inadequate response. Night time dosing is recommended because agomelatine improves the quality of sleep without day time sedation.

For oral administration with or without food. Most adult patients should take a dosage of 25 mg (one tablet) daily. It is usually taking prior to bed time. If no improvement is noticed after two weeks, the dosage can be increased to 50 mg (two tablets) daily.

The commonly reported adverse effects in the clinical trials of agomelatine are headache, nausea and diarrhea.

It is contraindicated in patients with hepatic impairment and hypersensitivity to the active substances or any of the excipients.

It is found to increase the level of liver enzymes and so monitoring of enzyme level is warranted before starting therapy and therefore every 6 weeks.

Potential interactions affecting agomelatine: Agomelatine is metabolised mainly by cytochrome P450 1A2 (CYP1A2) (90%) and by CYP2C9 (10%). Medicinal products that interact with these isoenzymes may decrease or increase the bioavailability of agomelatine. Fluvoxamine, a potent CYP1A2 and moderate CYP2C9 inhibitor markedly inhibits the metabolism of agomelatine resulting in a 60-fold (range 12-412) increase of agomelatine exposure. Consequently, co-administration of agomelatine with potent CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin) is contraindicated.

For agomelatine, no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see Toxicology: Preclinical Safety Data under Actions). Caution should be exercised when prescribing to pregnant women. It is not known whether Agomelatine is excreted into human milk. agomelatine or its metabolites are excreted in the milk of lactating rats. Potential effects of agomelatine on the breastfeeding infant have not been established. If treatment with agomelatine is considered necessary, breastfeeding should be discontinued.

Children under 18 years: Should be given only on medical advice.

Children and adolescents: Agomelatine is not recommended in the treatment of depression in patients .

Use in the elderly: Efficacy has not been clearly demonstrated in the elderly (65 years). Only limited clinical data is available on the use of Agomelatine in elderly patients 65 years with major depressive episodes. Therefore, caution should be exercised when prescribing Agomelatine to these patients.

There is limited experience with agomelatine overdose. During the clinical development, there were a few reports of agomelatine overdose, taken alone (up to 450 mg) or in combination (up to 525 mg) with other psychotropic medicinal products. Signs and symptoms of overdose were limited and included drowsiness and epigastralgia. No specific antidotes for agomelatine are known. Management of overdose should consist of treatment of clinical symptoms and routine monitoring. Medical follow-up in a specialised environment is recommended.

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

Digoxin is indicated in:

• Heart failure.
• Atrial fibrillation with an uncontrolled ventricular rate.
• Acute left ventricular failure.
• Chronic left ventricular failure and conjestive heart failure,especially when caused by hypertensive valvular (especially mitral valvular) disease or ischaemic heart disease.

Positive Inotropic drugs

Digoxin is a cardiac glycoside used in the management of particularly atrial fibrillation and in heart failure.The principal actions of digoxin are an increase in the force of myocardial contraction (positive inotropic activity and a reduction in the conductivity of the heart particularly in conduction through the atrioventricular node. Digoxin also has a direct action on vascular smooth muscle and indirect effects mediated primarily by the autonomic nervous system and particularly by an increase in vagal activity.

By oral administration:

• Rapid digitalization: 1-1.5 mg in divided doses over 24 hours
• Less urgent digitalization: 250-500 micrograms daily (higher dose may be divided)
• Maintenance: 62.5-500 micrograms daily (higher dose may be divided) according to renal function and in atrial fibrillation on heart rate response.
• Usual range: 125-250 micrograms daily (lower dose may be divided) according to renal function and in atrial fibrilation on heart rate response.
• Usual range: 125-250 micrograms daily (lower dose may be appropriate in the elderly).

Usually associated with excessive dosage include anorexia, nausea, vomiting, diarrhoea, abdominal pain, visual disturbance, headache, fatigue, drowsiness, confusion, delirium, hallucination, depression, arrhythmia, heart block, intestinal ischaemia, gynaecomastia on long term use, thrombocytopenia reported. Digoxin can be safely used in pregnancy

Potassium-depleting diuretics increase the effects of digitalis. Calcium particularly if administered rapidly by the intravenous route, may produce serious arrhythmia in digitalized patients. Quinidine, verapamil, amiodarone, propafenone, indomethacin, itraconazole, alprazolam, spironolactone, erythromycin, clarithromycin (and possibly other macrolide antibiotics) and tetracycline increase digoxin serum level. Besides antacids, kaolinpectin, sulfasalazine, neomycin, penicillamine, calestipol, metoclopramide, rifampin may interfere with intestinal absorption of digoxin resulting low serum concentrations of the drug.

Digoxin is excreted in breast milk but in concentration below those found in plasma and therefore poses no hazard to the breast-fed infant.

Neonates: Digoxin can be used in neonates.

Children: Digoxin can be used in children.

The elderly: Partly because of reduced renal function and partly because their tissues are more sensitive to the effects of digitalis, the elderly require a lower maintenance dose of digoxin than younger adults.

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

Prophylaxis of influenza (flu), especially in those who run an increased risk of associated complications. The use of Inactivated Influenza Vaccine should be based on official recommendations.

Vaccines, Anti-sera & Immunoglobulin

Dosage:

• Adults and children over 36 months of age: 0.5ml
• Children from 6 to 35 months of age: clinical data are limited. Doses of 0.25 ml or 0.5 ml have been used.

Administrations: For children who have not previously been vaccinated, a second dose should be given after an interval of at least 4 weeks. If half a dose (0.25 ml) is to be administered, discard half the contained volume (up to the mark indicated on the syringe barrel), before injection. Immunisation should be carried out by intramuscular or deep subcutaneous injection. The vaccine should be allowed to reach room temperature before use. Shake before use. Seroprotection is generally obtained within 2 to 3 weeks. The duration of postvaccinal immunity to homologous strains or to strains closely related to the vaccine strains varies but is usually 6-12 months.

Hypersensitivity to the active substances, to any of the excipients and to residues, e.g. eggs, chicken proteins, such as ovalbumin. The vaccine may contain residues of the following substances, e.g. kanamycin and neomycin sulphate, formaldehyde, cetyltrimethylammonium bromide (CTAB) and polysorbate 80. Immunisation shall be postponed in patients with febrile illness or acute infection.

Antibody response in patients with endogenous (due to illness) or iatrogenic (due to medicine) immunosuppression (poor immune response) may be insufficient. As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine. Inactivated Influenza Vaccine should under no circumstances be administered intravascularly.

Inactivated Influenza Vaccine may be given at the same time as other vaccines. Immunisation should be carried out on separate limbs. It should be noted that the adverse reactions may be intensified. The immunological response may be diminished if the patient is undergoing immunosuppressant treatment. Following influenza vaccination, false positive results in serology tests using the ELISA method (blood test) to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed. The Western Blot technique disproves the false-positive ELISA results. The transient false positive reactions could be due to the IgM response by the vaccine.

The limited data from vaccinations in pregnant women do not indicate that adverse foetal and maternal outcomes were attributable to the vaccine. The use of this vaccine may be considered from the second trimester of pregnancy. For pregnant women with medical conditions that increase their risk of complications from influenza, administration of the vaccine is recommended, irrespective of their stage of pregnancy. Inactivated Influenza Vaccine may be used during lactation.

Inactivated Influenza Vaccine must be stored in a refrigerator (2°C-8°C). Do not freeze. Keep the syringe in the outer carton in order to protect from light. Any unused product or waste material should be disposed of in accordance with local requirements.

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

Dilofenac Sodium is a potent non-steroidal anti-inflammatory drug (NSAID) with pronounced anti-rheumatic, anti-inflammatory, analgesic and antipyretic properties. It has also some uricosuric effect. Diclofenac exerts its effect by inhibiting prostaglandin biosynthesis which plays a major role in causing inflammation, pain and fever. Diclofenac is rapidly and completely absorbed from the gastro-intestinal tract when taken with or after meal. Peak plasma concentrations are reached within an average of 2 hours after ingestion of it. At therapeutic concentrations, it is 99.7% bound to plasma proteins. Diclofenac is metabolized in the liver and undergoes first pass metabolism.

Diclofenac FC Tablet: Adults: 75-150 mg daily in 2 to 3 divided doses, preferably after food. Dose should be reduced in long term use.

Diclofenac SR Tablet:

• Adult: 1 tablet daily, taken whole with liquid, preferably at meal times. If necessary, the daily dose can be increased to 150 mg by supplementation with conventional tablets.
• Children: 1-3 mg of diclofenac/kg body wt. daily in divided doses.
• Elderly patients: In elderly or debilitated patients, the lowest effective dosage is recommended, although the pharmacokinetics of diclofenac sodium is not impaired to any clinically relevant extent in elderly patients.

Diclofenac Dispersible Tablet:

• Adults: The recommended daily dosage is 2-3 tablets and the maximum daily dose is 150 mg. In milder cases, 2 tablets of Diclofenac DT per day are sufficient. Diclofenac DT should preferably be taken before meals.
• Children: Diclofenac is not recommended in children for other indications except juvenile rheumatoid arthritis where the recommended dose is 1-3 mg/kg body weight. Diclofenac DT is to be dropped into a half-glass of water and the liquid is to be stirred to aid dispersion before swallowing. There is no information on the use of Diclofenac DT for more than 03 months.

Diclofenac TR Capsule: One capsule daily. Diclofenac TR should be taken preferably after mealtimes.

Diclofenac Suppository: For adults: 50 mg suppository 2-3 times daily. Maximum daily dose is 150 mg.

Diclofenac injection: For adults the usual dose is 1 ampoule daily. In serious cases this dose may be increased up to 2 ampoules daily.

Diclofenac Gel: For external use only. Depending on the size of area to be treated, 2-4 g of Diclofenac gel should be applied to the skin 3-4 times daily. To the affected area gel should be rubbed in lightly. This gel may also be given in addition to further treatment with other dosage forms of Diclofenac.

Diclofenac Sodium is generally well tolerated. Adverse effects are mild, rare and transient. At the starting of the treatment, however, patients may be sometimes complaining of epigastric pain, eructation, nausea and diarrhea or dizziness or headache. These effects are usually mild in nature. Peripheral edema and skin reactions, such as rash and eczema have also been encountered. Diclofenac Sodium Gel may cause local irritation and reddening of the skin and skin rash.

Contraindicated to the patients hypersensitive to any ingredient of the products. Peptic ulcer, hypersensitivity to Diclofenac like other non-steroid anti-inflammatory agents, Diclofenac is also contra-indicated in asthmatic patient in whom attack with asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or by other drugs with prostaglandin synthetase inhibitor. This Gel should not be used under occlusive airtight dressings.

In rare instances where peptic ulceration or gastrointestinal bleeding occurs in patients under treatment with Diclofenac. In patients with advanced age should be kept under close observation. Diclofenac Sodium Gel should not be allowed to come in contact with the eyes or mucus membranes, after application the hands should be washed properly and not to be taken by mouth.

During pregnancy, Diclofenac should be employed only for compelling reasons. The lowest effective dose should be used. These types of drugs are not recommended during the first trimester of pregnancy. In view of insufficient clinical data, Diclofenac Sodium Gel is not recommended during pregnancy. A very insignificant quantity of Diclofenac may be detected in breast milk but no undesirable effects on the infant to be expected.

Store in a cool and dry place, protected from light. Store below 30°C. Keep out of the reach of children.

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

Dilofenac Sodium is a potent non-steroidal anti-inflammatory drug (NSAID) with pronounced anti-rheumatic, anti-inflammatory, analgesic and antipyretic properties. It has also some uricosuric effect. Diclofenac exerts its effect by inhibiting prostaglandin biosynthesis which plays a major role in causing inflammation, pain and fever. Diclofenac is rapidly and completely absorbed from the gastro-intestinal tract when taken with or after meal. Peak plasma concentrations are reached within an average of 2 hours after ingestion of it. At therapeutic concentrations, it is 99.7% bound to plasma proteins. Diclofenac is metabolized in the liver and undergoes first pass metabolism.

Diclofenac FC Tablet: Adults: 75-150 mg daily in 2 to 3 divided doses, preferably after food. Dose should be reduced in long term use.

Diclofenac SR Tablet:

• Adult: 1 tablet daily, taken whole with liquid, preferably at meal times. If necessary, the daily dose can be increased to 150 mg by supplementation with conventional tablets.
• Children: 1-3 mg of diclofenac/kg body wt. daily in divided doses.
• Elderly patients: In elderly or debilitated patients, the lowest effective dosage is recommended, although the pharmacokinetics of diclofenac sodium is not impaired to any clinically relevant extent in elderly patients.

Diclofenac Dispersible Tablet:

• Adults: The recommended daily dosage is 2-3 tablets and the maximum daily dose is 150 mg. In milder cases, 2 tablets of Diclofenac DT per day are sufficient. Diclofenac DT should preferably be taken before meals.
• Children: Diclofenac is not recommended in children for other indications except juvenile rheumatoid arthritis where the recommended dose is 1-3 mg/kg body weight. Diclofenac DT is to be dropped into a half-glass of water and the liquid is to be stirred to aid dispersion before swallowing. There is no information on the use of Diclofenac DT for more than 03 months.

Diclofenac TR Capsule: One capsule daily. Diclofenac TR should be taken preferably after mealtimes.

Diclofenac Suppository: For adults: 50 mg suppository 2-3 times daily. Maximum daily dose is 150 mg.

Diclofenac injection: For adults the usual dose is 1 ampoule daily. In serious cases this dose may be increased up to 2 ampoules daily.

Diclofenac Gel: For external use only. Depending on the size of area to be treated, 2-4 g of Diclofenac gel should be applied to the skin 3-4 times daily. To the affected area gel should be rubbed in lightly. This gel may also be given in addition to further treatment with other dosage forms of Diclofenac.

Diclofenac Sodium is generally well tolerated. Adverse effects are mild, rare and transient. At the starting of the treatment, however, patients may be sometimes complaining of epigastric pain, eructation, nausea and diarrhea or dizziness or headache. These effects are usually mild in nature. Peripheral edema and skin reactions, such as rash and eczema have also been encountered. Diclofenac Sodium Gel may cause local irritation and reddening of the skin and skin rash.

Contraindicated to the patients hypersensitive to any ingredient of the products. Peptic ulcer, hypersensitivity to Diclofenac like other non-steroid anti-inflammatory agents, Diclofenac is also contra-indicated in asthmatic patient in whom attack with asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or by other drugs with prostaglandin synthetase inhibitor. This Gel should not be used under occlusive airtight dressings.

In rare instances where peptic ulceration or gastrointestinal bleeding occurs in patients under treatment with Diclofenac. In patients with advanced age should be kept under close observation. Diclofenac Sodium Gel should not be allowed to come in contact with the eyes or mucus membranes, after application the hands should be washed properly and not to be taken by mouth.

During pregnancy, Diclofenac should be employed only for compelling reasons. The lowest effective dose should be used. These types of drugs are not recommended during the first trimester of pregnancy. In view of insufficient clinical data, Diclofenac Sodium Gel is not recommended during pregnancy. A very insignificant quantity of Diclofenac may be detected in breast milk but no undesirable effects on the infant to be expected.

Store in a cool and dry place, protected from light. Store below 30°C. Keep out of the reach of children.

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

Dilofenac Sodium is a potent non-steroidal anti-inflammatory drug (NSAID) with pronounced anti-rheumatic, anti-inflammatory, analgesic and antipyretic properties. It has also some uricosuric effect. Diclofenac exerts its effect by inhibiting prostaglandin biosynthesis which plays a major role in causing inflammation, pain and fever. Diclofenac is rapidly and completely absorbed from the gastro-intestinal tract when taken with or after meal. Peak plasma concentrations are reached within an average of 2 hours after ingestion of it. At therapeutic concentrations, it is 99.7% bound to plasma proteins. Diclofenac is metabolized in the liver and undergoes first pass metabolism.

Diclofenac FC Tablet: Adults: 75-150 mg daily in 2 to 3 divided doses, preferably after food. Dose should be reduced in long term use.

Diclofenac SR Tablet:

• Adult: 1 tablet daily, taken whole with liquid, preferably at meal times. If necessary, the daily dose can be increased to 150 mg by supplementation with conventional tablets.
• Children: 1-3 mg of diclofenac/kg body wt. daily in divided doses.
• Elderly patients: In elderly or debilitated patients, the lowest effective dosage is recommended, although the pharmacokinetics of diclofenac sodium is not impaired to any clinically relevant extent in elderly patients.

Diclofenac Dispersible Tablet:

• Adults: The recommended daily dosage is 2-3 tablets and the maximum daily dose is 150 mg. In milder cases, 2 tablets of Diclofenac DT per day are sufficient. Diclofenac DT should preferably be taken before meals.
• Children: Diclofenac is not recommended in children for other indications except juvenile rheumatoid arthritis where the recommended dose is 1-3 mg/kg body weight. Diclofenac DT is to be dropped into a half-glass of water and the liquid is to be stirred to aid dispersion before swallowing. There is no information on the use of Diclofenac DT for more than 03 months.

Diclofenac TR Capsule: One capsule daily. Diclofenac TR should be taken preferably after mealtimes.

Diclofenac Suppository: For adults: 50 mg suppository 2-3 times daily. Maximum daily dose is 150 mg.

Diclofenac injection: For adults the usual dose is 1 ampoule daily. In serious cases this dose may be increased up to 2 ampoules daily.

Diclofenac Gel: For external use only. Depending on the size of area to be treated, 2-4 g of Diclofenac gel should be applied to the skin 3-4 times daily. To the affected area gel should be rubbed in lightly. This gel may also be given in addition to further treatment with other dosage forms of Diclofenac.

Diclofenac Sodium is generally well tolerated. Adverse effects are mild, rare and transient. At the starting of the treatment, however, patients may be sometimes complaining of epigastric pain, eructation, nausea and diarrhea or dizziness or headache. These effects are usually mild in nature. Peripheral edema and skin reactions, such as rash and eczema have also been encountered. Diclofenac Sodium Gel may cause local irritation and reddening of the skin and skin rash.

Contraindicated to the patients hypersensitive to any ingredient of the products. Peptic ulcer, hypersensitivity to Diclofenac like other non-steroid anti-inflammatory agents, Diclofenac is also contra-indicated in asthmatic patient in whom attack with asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or by other drugs with prostaglandin synthetase inhibitor. This Gel should not be used under occlusive airtight dressings.

In rare instances where peptic ulceration or gastrointestinal bleeding occurs in patients under treatment with Diclofenac. In patients with advanced age should be kept under close observation. Diclofenac Sodium Gel should not be allowed to come in contact with the eyes or mucus membranes, after application the hands should be washed properly and not to be taken by mouth.

During pregnancy, Diclofenac should be employed only for compelling reasons. The lowest effective dose should be used. These types of drugs are not recommended during the first trimester of pregnancy. In view of insufficient clinical data, Diclofenac Sodium Gel is not recommended during pregnancy. A very insignificant quantity of Diclofenac may be detected in breast milk but no undesirable effects on the infant to be expected.

Store in a cool and dry place, protected from light. Store below 30°C. Keep out of the reach of children.

Levosalbutamol is indicated for the treatment or prevention of bronchospasm in adults, adolescents and children 6 years of age and older with reversible obstructive airway disease.

Short-acting selective & β2-adrenoceptor stimulants

Levosalbutamol is a single isomer beta 2-agonist that differs from racemic salbutamol by elimination of (S)-salbutamol. Levosalbutamol is an effective bronchodilator whose primary mechanism of action is unimpeded by (S)-salbutamol. Thus, when compared with racemic salbutamol, clinically comparable bronchodilation can be achieved with doses that substantially lessen beta-mediated side effects.

Tablet-

• Adults and adolescents above 12 years: 1-2 mg three times daily.
• Children (6 -11 years): 1 mg three times daily.

Syrup-

• Adults : 5-10 ml three times daily.
• Childrn (6-11 years): 5 ml three times daily.

Hypocalcaemia, palpitation, fine tremors of the skeletal muscle and muscle cramps may occur. The other likely side effects are nausea, vomiting, burning substernal or epigastric pain and diarrhoea.

Levosalbutamol is contraindicated in patients with a history of hypersensitivity to levosalbutamol or any of its components.

Particular caution is advised in acute severe asthma as this effect may be potentiated by hypoxia and by concomitant treatment with xanthine derivatives, steroids and diuretics. Serum potassium levels should be monitored in such situations.

Other short acting sympathomimetic bronchodilators or epinephrine should be used with caution with Levosalbutamol. If additional adrenergic drugs are to be administered by any route, they will be used with caution to avoid deleterious cardiovascular effects.

The drug should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus. It is not known whether Levosalbutamol is excreted in human milk. Caution should be exercised when oral Levosalbutamol is administered to a nursing woman.

The expected symptoms with over dosage are those of excessive beta-adrenergic stimulation and the symptoms listed under side effects. In the event of serious poisoning, the stomach should be emptied and, if necessary, a beta-blocker administered with caution in patients with a history of bronchospasm.

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

Levosalbutamol is indicated for the treatment or prevention of bronchospasm in adults, adolescents and children 6 years of age and older with reversible obstructive airway disease.

Short-acting selective & β2-adrenoceptor stimulants

Levosalbutamol is a single isomer beta 2-agonist that differs from racemic salbutamol by elimination of (S)-salbutamol. Levosalbutamol is an effective bronchodilator whose primary mechanism of action is unimpeded by (S)-salbutamol. Thus, when compared with racemic salbutamol, clinically comparable bronchodilation can be achieved with doses that substantially lessen beta-mediated side effects.

Tablet-

• Adults and adolescents above 12 years: 1-2 mg three times daily.
• Children (6 -11 years): 1 mg three times daily.

Syrup-

• Adults : 5-10 ml three times daily.
• Childrn (6-11 years): 5 ml three times daily.

Hypocalcaemia, palpitation, fine tremors of the skeletal muscle and muscle cramps may occur. The other likely side effects are nausea, vomiting, burning substernal or epigastric pain and diarrhoea.

Levosalbutamol is contraindicated in patients with a history of hypersensitivity to levosalbutamol or any of its components.

Particular caution is advised in acute severe asthma as this effect may be potentiated by hypoxia and by concomitant treatment with xanthine derivatives, steroids and diuretics. Serum potassium levels should be monitored in such situations.

Other short acting sympathomimetic bronchodilators or epinephrine should be used with caution with Levosalbutamol. If additional adrenergic drugs are to be administered by any route, they will be used with caution to avoid deleterious cardiovascular effects.

The drug should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus. It is not known whether Levosalbutamol is excreted in human milk. Caution should be exercised when oral Levosalbutamol is administered to a nursing woman.

The expected symptoms with over dosage are those of excessive beta-adrenergic stimulation and the symptoms listed under side effects. In the event of serious poisoning, the stomach should be emptied and, if necessary, a beta-blocker administered with caution in patients with a history of bronchospasm.

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

Montelukast Sodium is indicated for:

• Prophylaxis and chronic treatment of asthma
• Acute prevention of Exercise-Induced Bronchoconstriction (EIB)
• Relief of symptoms of Allergic Rhinitis (AR): Seasonal & Perennial Allergic Rhinitis

Leukotriene receptor antagonists

Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor (CysLT₁). The cysteinyl leukotrienes (LTC₄, LTD₄, LTE₄) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma & allergic rhinitis, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma.

Adults & adolescents (15 years & older)-

• Asthma & Allergic Rhinitis: 10 mg/day 
• Exercise-Induced Bronchoconstriction: 10 mg/day

Pediatric patients (6 to 14 years)-

• Asthma & Allergic Rhinitis: 5 mg/day 
• Exercise-Induced Bronchoconstriction: 5 mg/day

Pediatric patients (6 months to 5 years)-

• Asthma & Allergic Rhinitis: 4 mg/day 
• Exercise-Induced Bronchoconstriction: Not recommended

Patients with both asthma and allergic rhinitis should take only one dose daily in the evening. For prevention of Acute prevention of Exercise-Induced Bronchoconstriction, a single dose should be taken at least 2 hours before exercise.

Route of administration: Oral. Montelukast may be taken with or without food or as directed by the physician.

Common: Diarrhoea, fever, gastrointestinal discomfort, headache, nausea, vomiting, skin reactions, upper respiratory tract infection.

Uncommon: Akathisia, anxiety, arthralgia, asthenia, abnormal behavior, depression, dizziness, drowsiness, dry mouth, haemorrhage, irritability, malaise, muscle complaints, oedema, seizure, abnormal sensation, sleep disorders.

Rare: Angioedema, concentration impaired, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, suicidal tendencies, tremor.

Montelukast is contraindicated in patients who are hypersensitive to any component of this product.

Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmatic. Neuropsychiatric events including agitation, hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide) and tremor.

With medicine: No dose adjustment is needed when montelukast is co-administered with theophylline, prednisone, prednisolone, terfenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative-hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, oral contraceptives, and Cytochrome P450 (CYP) enzyme inducers.

With food and others: Bioavailability and other conditions were not significantly observed with food & other conditions.

There are no adequate and well-controlled studies in pregnant women. Montelukast should be used during pregnancy only if clearly needed. Montelukast is excreted in breast milk. So caution should be exercised when Montelukast is given to a nursing mother.

There were no adverse experiences in the majority of overdosage reports. The most frequently occurring adverse experiences were consistent with the safety profile of Montelukast and included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required.

Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.

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.

Cromoglycate & related drugs

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.

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.

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.

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.

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.

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.

Although there is no evidence of any teratogenic effect, Ketotifen in pregnancy and lactation is not recommended.

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.

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

Levosalbutamol is indicated for the treatment or prevention of bronchospasm in adults, adolescents and children 6 years of age and older with reversible obstructive airway disease.

Short-acting selective & β2-adrenoceptor stimulants

Levosalbutamol is a single isomer beta 2-agonist that differs from racemic salbutamol by elimination of (S)-salbutamol. Levosalbutamol is an effective bronchodilator whose primary mechanism of action is unimpeded by (S)-salbutamol. Thus, when compared with racemic salbutamol, clinically comparable bronchodilation can be achieved with doses that substantially lessen beta-mediated side effects.

Tablet-

• Adults and adolescents above 12 years: 1-2 mg three times daily.
• Children (6 -11 years): 1 mg three times daily.

Syrup-

• Adults : 5-10 ml three times daily.
• Childrn (6-11 years): 5 ml three times daily.

Hypocalcaemia, palpitation, fine tremors of the skeletal muscle and muscle cramps may occur. The other likely side effects are nausea, vomiting, burning substernal or epigastric pain and diarrhoea.

Levosalbutamol is contraindicated in patients with a history of hypersensitivity to levosalbutamol or any of its components.

Particular caution is advised in acute severe asthma as this effect may be potentiated by hypoxia and by concomitant treatment with xanthine derivatives, steroids and diuretics. Serum potassium levels should be monitored in such situations.

Other short acting sympathomimetic bronchodilators or epinephrine should be used with caution with Levosalbutamol. If additional adrenergic drugs are to be administered by any route, they will be used with caution to avoid deleterious cardiovascular effects.

The drug should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus. It is not known whether Levosalbutamol is excreted in human milk. Caution should be exercised when oral Levosalbutamol is administered to a nursing woman.

The expected symptoms with over dosage are those of excessive beta-adrenergic stimulation and the symptoms listed under side effects. In the event of serious poisoning, the stomach should be emptied and, if necessary, a beta-blocker administered with caution in patients with a history of bronchospasm.

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

Montelukast Sodium is indicated for:

• Prophylaxis and chronic treatment of asthma
• Acute prevention of Exercise-Induced Bronchoconstriction (EIB)
• Relief of symptoms of Allergic Rhinitis (AR): Seasonal & Perennial Allergic Rhinitis

Leukotriene receptor antagonists

Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor (CysLT₁). The cysteinyl leukotrienes (LTC₄, LTD₄, LTE₄) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma & allergic rhinitis, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma.

Adults & adolescents (15 years & older)-

• Asthma & Allergic Rhinitis: 10 mg/day 
• Exercise-Induced Bronchoconstriction: 10 mg/day

Pediatric patients (6 to 14 years)-

• Asthma & Allergic Rhinitis: 5 mg/day 
• Exercise-Induced Bronchoconstriction: 5 mg/day

Pediatric patients (6 months to 5 years)-

• Asthma & Allergic Rhinitis: 4 mg/day 
• Exercise-Induced Bronchoconstriction: Not recommended

Patients with both asthma and allergic rhinitis should take only one dose daily in the evening. For prevention of Acute prevention of Exercise-Induced Bronchoconstriction, a single dose should be taken at least 2 hours before exercise.

Route of administration: Oral. Montelukast may be taken with or without food or as directed by the physician.

Common: Diarrhoea, fever, gastrointestinal discomfort, headache, nausea, vomiting, skin reactions, upper respiratory tract infection.

Uncommon: Akathisia, anxiety, arthralgia, asthenia, abnormal behavior, depression, dizziness, drowsiness, dry mouth, haemorrhage, irritability, malaise, muscle complaints, oedema, seizure, abnormal sensation, sleep disorders.

Rare: Angioedema, concentration impaired, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, suicidal tendencies, tremor.

Montelukast is contraindicated in patients who are hypersensitive to any component of this product.

Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmatic. Neuropsychiatric events including agitation, hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide) and tremor.

With medicine: No dose adjustment is needed when montelukast is co-administered with theophylline, prednisone, prednisolone, terfenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative-hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, oral contraceptives, and Cytochrome P450 (CYP) enzyme inducers.

With food and others: Bioavailability and other conditions were not significantly observed with food & other conditions.

There are no adequate and well-controlled studies in pregnant women. Montelukast should be used during pregnancy only if clearly needed. Montelukast is excreted in breast milk. So caution should be exercised when Montelukast is given to a nursing mother.

There were no adverse experiences in the majority of overdosage reports. The most frequently occurring adverse experiences were consistent with the safety profile of Montelukast and included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required.

Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.