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SB-Mezol

Metronidazole

Tablet 400 mg Allopathic Amoebicides

Indications

Vaginal trichomoniasis

Indication detailsView

Metronidazole is indicated in the treatment of following diseases:

The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
In the treatment of urogenital trichomoniasis.
Bacterial vaginosis (also known as non-specific vaginitis).
All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
Giardiasis.
Acute ulcerative gingivitis.
Anaerobically infected leg ulcers and pressure sores.
Acute dental infections due to anaerobic organisms.
Antibiotic associated pseudomembranus colitis.

Therapeutic classView

Amoebicides, Anti-diarrhoeal Antiprotozoal

PharmacologyView

Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.

DosageView

Tablet and Suspension:

Trichomoniasis (Adults & Children over 10 yrs)-

200 mg tid or 400 mg bid for 7 days
800 mg in the morning and 1-2 gm at night for 2 days
2 gm as a single dose for 1 days

Trichomoniasis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Intestinal amoebiasis (Adults & Children over 10 yrs)-

800 mg tid for 5 days

Intestinal amoebiasis (Children)-

Children 7-10 yrs: 400 mg tid
Children 3-7 yrs: 200 mg qid
Children 1-3 yrs: 200 mg tid

Extra-intestinal & Asymptomatic amoebiasis (Adults & Children over 10 yrs)-

400-800 mg tid for 5-10 days

Extra-intestinal & Asymptomatic amoebiasis (Children)-

Children 7-10 yrs: 200-400 mg tid
Children 3-7 yrs: 100-200 mg qid
Children 1-3 yrs: 100-200 mg tid

Giardiasis (Adults & Children over 10 yrs)-

2 gm once daily for 3 days

Giardiasis (Children)-

Children 7-10 yrs: 1 gm once daily
Children 3-7 yrs: 600-800 mg once daily
Children 1-3 yrs: 500 mg once daily

Acute ulcerative gingivitis (Adults & Children over 10 yrs)-

200 mg tid for 3 days

Acute ulcerative gingivitis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Acute dental infections (Adults & Children over 10 yrs)-

200 mg tid for 3-7 days

Bacterial Vaginosis (Adults & Children over 10 yrs)-

400 mg bid for 7 days
2 gm as a single dose for 1 days

Leg ulcers and pressure sores (Adults & Children over 10 yrs)-

400 mg tid for 7 days

Anaerobic infections (Adults & Children over 10 yrs)-

800 mg initially and then 400 mg tid for 7 days

Anaerobic infections (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Surgical prophylaxis (Adults & Children over 10 yrs)-

400 mg tid started 24 hours before surgery for 1 days

Surgical prophylaxis (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Vaginal Gel:

The recommended dose is one applicator full of Metronidazole gel (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole gel should be administered at bedtime.

Suppository:

Anaerobic Infections-

Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.

Surgical Prophylaxis-

Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.

IV Infusion:

Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.

Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.

Side effectsView

Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.

ContraindicationsView

Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.

PrecautionsView

If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
Metronidazole should be administered with caution to patients with hepatic encephalopathy.
Patients should be warned that metronidazole may darken urine.

InteractionsView

Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
Lithium: Plasma levels of lithium may be increased by metronidazole.
Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.

Pregnancy & lactationView

US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.

Pediatric usageView

Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.

Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).

Overdose effectsView

Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.

StorageView

Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.

SB-Monec

Montelukast Sodium

Tablet 10 mg Allopathic Leukotriene receptor antagonists

Indications

Rhinitis

Indication detailsView

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

Therapeutic classView

Leukotriene receptor antagonists

PharmacologyView

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.

DosageView

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.

AdministrationView

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

Side effectsView

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.

ContraindicationsView

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

PrecautionsView

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.

InteractionsView

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.

Pregnancy & lactationView

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.

Overdose effectsView

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.

StorageView

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

SB-Neurec

Vitamin B1, B6 & B12

Tablet 100 mg+200 mg+200 mcg Allopathic Specific combined vitamin preparations

Indications

Vitamin B deficiencies

Indication detailsView

Vitamin B1, B6 & B12 is indicated for the treatment of vitamin B1, B6 & B12 deficiency syndrome. It is also indicated for the supportive treatment of neuritis & non-inflammatory diseases of the nerves, e.g.- Diabetic neuropathy, Peripheral neuralgin, Lumbago, Myalgia, Optic neuritis, Sciatica, Facial neuralgia, Intercostal neuralgia, Spinal pain.

Therapeutic classView

Specific combined vitamin preparations

PharmacologyView

Vitamin B1 converts carbohydrates, fatty acids and amino acids into energy, promotes healthy nerves, improves mood, strengthens the heart. Vitamin B6 forms RBCs, helps cells to make proteins, manufactures neurotransmitters e.g. serotonin and releases stored forms of energy, helps to prevent CVS diseases and stroke, helps to lift depression and eases insomnia. Vitamin B12 is essential for cell replication and important for RBC production, prevents anemia, helps to prevent depression, reduces nerve pain, numbness, tingling and lowers the risk of heart diseases.

The vitamin ingredients are absorbed well in per oral reception. It is widely distributed to most tissues and appears in breast milk. Within the cell, thiamine is mostly present as diphosphate. Thiamine is not stored to any appreciable extent in the body and amounts in excess of the body’s requirements are excreted in the urine as unchanged thiamine or as metabolites. Pyridoxine, pyridoxal and pyridoxamine are readily absorbed from the GIT following oral administration and are converted to the active forms of pyridoxal phosphate an pyridoxamine phosphate. They are stored mainly in liver where there is oxidation to 4-pyridoxic acid and other inactive metabolites, which are excreted in urine. As the dose increases, proportionally greater amounts are excreted unchanged in the urine.

DosageView

Tablet: 1-3 Tablets per day or as advised by the physician.

Injection:

In severe (acute) cases: 1 injection daily until the acute symptoms subside or taken as advised by the physician.
In mild cases: 1 injection 2-3 times per week. Ampoules are preferably injected intramuscularly.

Use in children: There is no information on the use of this drug in children.

Side effectsView

Generally well tolerated but allergic reactions may be observed in few cases.

ContraindicationsView

Vitamin B1, Vitamin B6 and Vitamin B12 is contraindicated in patients on levodopa therapy, and in patients with hypersensitivity to any of the ingredients of the preparation.

PrecautionsView

Cyanocobalamin should not be given in patients with subacute degeneration of the spinal cord. Cyanocobalamin is not suitable form of vitamin B12 for the treatment of optic neuropathies associated with raised plasma concentrations of cyanocobalamin.

InteractionsView

No drug interaction has been reported yet.

Pregnancy & lactationView

Oral tablet form is recommended but due to the presence of benzyl alcohol, injection is not recommended during pregnancy & lactation.

Overdose effectsView

No overdosage symptoms are to be expected in the recommended dosage. If there is known overdose then treatment is symptomatic & supportive.

StorageView

Keep out of reach of children. Store in a cool (below 25°C temperature) and dry place, protected from light.

SB-Omec

Omeprazole

Capsule (Delayed Release) 40 mg Allopathic Proton Pump Inhibitor

Indications

Zollinger-Ellison syndrome

Indication detailsView

Omeprazole is indicated for the treatment of-

Gastric and duodenal ulcer
NSAID-associated duodenal and gastric ulcer
As prophylaxis in patients with a history of NSAID-associated duodenal and gastric ulcer
Gastro-esophageal reflux disease
Long-term management of acid reflux disease
Acid-related dyspepsia
Severe ulcerating reflux esophagitis
Prophylaxis of acid aspiration during general anesthesia
Zollinger-Ellison syndrome
Helicobacter pylori-induced peptic ulcer.

Therapeutic classView

Proton Pump Inhibitor

PharmacologyView

Omeprazole, a substituted benzimidazole, is an inhibitor of gastric acid secretion. It inhibits gastric acid secretion by blocking hydrogen-potassium-adenosine triphosphatase (H⁺/K⁺ ATPase) enzyme system in the gastric parietal cell. After oral administration, the onset of the antisecretory effect occurs within one hour, with the maximum effect occurring within two hours and inhibition of secretion lasts up to 72 hours. When the drug is discontinued, secretory activity returns gradually, over 3 to 5 days.

DosageView

Oral-

Benign gastric and duodenal ulcer: 20 mg once daily for 4 weeks in duodenal ulceration, 8 weeks in gastric ulceration; in severe or recurrent cases, dose to be increased to 40 mg daily; maintenance dose for recurrent duodenal ulcer, 20 mg once daily; in prevention of relapse in duodenal ulcer, 10-20 mg daily.
NSAID-associated duodenal or gastric ulcer: 20 mg once daily for 4 weeks, continued for further 4 weeks, if not fully healed. 20 mg once daily is used as prophylaxis in patients with a history of NSAID-associated duodenal or gastric ulcers.
Gastro-esophageal reflux disease: 20 mg once daily for 4 weeks, continued for further 4-8 weeks, if not fully healed; 40 mg once daily has been given for 8 weeks in gastro-esophageal reflux disease, refractory to other treatment; maintenance dose is 20 mg once daily.
Long-term management of acid reflux disease: 10-20 mg daily.
Acid-related dyspepsia: 10-20 mg once daily for 2-4 weeks.
Prophylaxis of acid aspiration: 40 mg on the preceding evening, then 40 mg 2-6 hours before surgery.
Zollinger-Ellison syndrome: Initially 60 mg once daily; usual range 20-120 mg daily (If daily dose is more than 80 mg, 2 divided dose should be used).
Helicobacter pylori eradication regimen in peptic ulcer disease: Omeprazole is recommended at a dose of 20 mg twice daily in association with antimicrobial agents as detailed below: Amoxicillin 500 mg and Metronidazole 400 mg both three times a day for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice a day for one week, or Amoxicillin 1 g and Clarithromycin 500 mg both twice a day for one week.
Paeditaric use in severe ulcerating reflux esophagitis (Child>1 year): If body-weight 10-20 kg, 10-20 -mg once daily for 4-12 weeks; if body-weight over 20 kg, 20-40 mg once daily for 4-12 weeks.

IV Injection-

Prophylaxis of acid aspiration: Omeprazole 40 mg to be given slowly (over a period of 5 minutes) as an intravenous injection, one hour before surgery.
Duodenal ulcer, gastric ulcer or reflux oesophagitis: In patients with duodenal ulcer, gastric ulcer or reflux oesophagitis where oral medication is inappropriate, Omeprazole IV 40 mg once daily is recommended.
Zollinger- Ellison syndrome (ZES): In patients with Zollinger-Ellison Syndrome the recommended initial dose of Omeprazole given intravenously is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided & given twice daily.

AdministrationView

Direction for use of IV Injection: Omeprazole lyophilized powder and water for injection is for intravenous administration only and must not be given by any other route. Omeprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml water for injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes at a maximum rate of 4 ml/minute. Use only freshly prepared solution. The solution should be used within 4 hours of reconstitution.

Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.

Side effectsView

Omeprazole is generally well tolerated. Nausea, abdominal colic, paresthesia, dizziness and headache have been stated to be generally mild and transient and not requiring a reduction in dosage.

ContraindicationsView

Omeprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.

PrecautionsView

When gastric ulcer is suspected, the possibility of gastric malignancy should be excluded before treatment with Omeprazole is instituted, as treatment may alleviate the symptoms and delay diagnosis.

InteractionsView

Omeprazole can prolong the elimination of diazepam, warfarin and phenytoin. So, reduction of warfarin or phenytoin dose may be necessary when Omeprazole is added to the treatment. There is no evidence of an interaction of Omeprazole with theophylline, propranolol or antacids.

Pregnancy & lactationView

US FDA pregnancy category of Omeprazole is C. However, results from three prospective epidemiological studies indicate no adverse effects of Omeprazole on pregnancy or on the health of the fetus/newborn child. There is no information available on the passage of Omeprazole into breast milk or its effects on the neonate. Breast-feeding should, therefore, be discontinued, if the use of Omeprazole is considered essential.

StorageView

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

SB-Omec

Omeprazole

Capsule (Delayed Release) 20 mg Allopathic Proton Pump Inhibitor

Indications

Zollinger-Ellison syndrome

Indication detailsView

Omeprazole is indicated for the treatment of-

Gastric and duodenal ulcer
NSAID-associated duodenal and gastric ulcer
As prophylaxis in patients with a history of NSAID-associated duodenal and gastric ulcer
Gastro-esophageal reflux disease
Long-term management of acid reflux disease
Acid-related dyspepsia
Severe ulcerating reflux esophagitis
Prophylaxis of acid aspiration during general anesthesia
Zollinger-Ellison syndrome
Helicobacter pylori-induced peptic ulcer.

Therapeutic classView

Proton Pump Inhibitor

PharmacologyView

Omeprazole, a substituted benzimidazole, is an inhibitor of gastric acid secretion. It inhibits gastric acid secretion by blocking hydrogen-potassium-adenosine triphosphatase (H⁺/K⁺ ATPase) enzyme system in the gastric parietal cell. After oral administration, the onset of the antisecretory effect occurs within one hour, with the maximum effect occurring within two hours and inhibition of secretion lasts up to 72 hours. When the drug is discontinued, secretory activity returns gradually, over 3 to 5 days.

DosageView

Oral-

Benign gastric and duodenal ulcer: 20 mg once daily for 4 weeks in duodenal ulceration, 8 weeks in gastric ulceration; in severe or recurrent cases, dose to be increased to 40 mg daily; maintenance dose for recurrent duodenal ulcer, 20 mg once daily; in prevention of relapse in duodenal ulcer, 10-20 mg daily.
NSAID-associated duodenal or gastric ulcer: 20 mg once daily for 4 weeks, continued for further 4 weeks, if not fully healed. 20 mg once daily is used as prophylaxis in patients with a history of NSAID-associated duodenal or gastric ulcers.
Gastro-esophageal reflux disease: 20 mg once daily for 4 weeks, continued for further 4-8 weeks, if not fully healed; 40 mg once daily has been given for 8 weeks in gastro-esophageal reflux disease, refractory to other treatment; maintenance dose is 20 mg once daily.
Long-term management of acid reflux disease: 10-20 mg daily.
Acid-related dyspepsia: 10-20 mg once daily for 2-4 weeks.
Prophylaxis of acid aspiration: 40 mg on the preceding evening, then 40 mg 2-6 hours before surgery.
Zollinger-Ellison syndrome: Initially 60 mg once daily; usual range 20-120 mg daily (If daily dose is more than 80 mg, 2 divided dose should be used).
Helicobacter pylori eradication regimen in peptic ulcer disease: Omeprazole is recommended at a dose of 20 mg twice daily in association with antimicrobial agents as detailed below: Amoxicillin 500 mg and Metronidazole 400 mg both three times a day for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice a day for one week, or Amoxicillin 1 g and Clarithromycin 500 mg both twice a day for one week.
Paeditaric use in severe ulcerating reflux esophagitis (Child>1 year): If body-weight 10-20 kg, 10-20 -mg once daily for 4-12 weeks; if body-weight over 20 kg, 20-40 mg once daily for 4-12 weeks.

IV Injection-

Prophylaxis of acid aspiration: Omeprazole 40 mg to be given slowly (over a period of 5 minutes) as an intravenous injection, one hour before surgery.
Duodenal ulcer, gastric ulcer or reflux oesophagitis: In patients with duodenal ulcer, gastric ulcer or reflux oesophagitis where oral medication is inappropriate, Omeprazole IV 40 mg once daily is recommended.
Zollinger- Ellison syndrome (ZES): In patients with Zollinger-Ellison Syndrome the recommended initial dose of Omeprazole given intravenously is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided & given twice daily.

AdministrationView

Direction for use of IV Injection: Omeprazole lyophilized powder and water for injection is for intravenous administration only and must not be given by any other route. Omeprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml water for injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes at a maximum rate of 4 ml/minute. Use only freshly prepared solution. The solution should be used within 4 hours of reconstitution.

Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.

Side effectsView

Omeprazole is generally well tolerated. Nausea, abdominal colic, paresthesia, dizziness and headache have been stated to be generally mild and transient and not requiring a reduction in dosage.

ContraindicationsView

Omeprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.

PrecautionsView

When gastric ulcer is suspected, the possibility of gastric malignancy should be excluded before treatment with Omeprazole is instituted, as treatment may alleviate the symptoms and delay diagnosis.

InteractionsView

Omeprazole can prolong the elimination of diazepam, warfarin and phenytoin. So, reduction of warfarin or phenytoin dose may be necessary when Omeprazole is added to the treatment. There is no evidence of an interaction of Omeprazole with theophylline, propranolol or antacids.

Pregnancy & lactationView

US FDA pregnancy category of Omeprazole is C. However, results from three prospective epidemiological studies indicate no adverse effects of Omeprazole on pregnancy or on the health of the fetus/newborn child. There is no information available on the passage of Omeprazole into breast milk or its effects on the neonate. Breast-feeding should, therefore, be discontinued, if the use of Omeprazole is considered essential.

StorageView

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

SB-Opa

Paracetamol

Tablet 500 mg Allopathic Non opioid analgesics

Indications

Toothache

Indication detailsView

Paracetamol is indicated for fever, common cold and influenza, headache, toothache, earache, bodyache, myalgia, neuralgia, dysmenorrhoea, sprains, colic pain, back pain, post-operative pain, postpartum pain, inflammatory pain and post vaccination pain in children. It is also indicated for rheumatic & osteoarthritic pain and stiffness of joints.

Therapeutic classView

Non opioid analgesics

PharmacologyView

Paracetamol has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol (Acetaminophen) is thought to act primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin (PG) synthesis. Paracetamol is a para aminophenol derivative, has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol is one of the most widely used, safest and fast acting analgesic. It is well tolerated and free from various side effects of aspirin.

DosageView

Tablet:

Adult: 1-2 tablets every 4 to 6 hours up to a maximum of 4 gm (8 tablets) daily.
Children (6-12 years): ½ to 1 tablet 3 to 4 times daily. For long term treatment it is wise not to exceed the dose beyond 2.6 gm/day.

Extended Release Tablet:

Adults & Children over 12 years: Two tablets, swallowed whole, every 6 to 8 hours (maximum of 6 tablets in any 24 hours).The tablet must not be crushed.

Syrup/Suspension:

Children under 3 months: 10 mg/kg body weight (reduce to 5 mg/kg if jaundiced) 3 to 4 times daily.
3 months to below 1 year: ½ to 1 teaspoonful 3 to 4 times daily.
1-5 years: 1 -2 teaspoonful 3 to 4 times daily.
6-12 years: 2-A teaspoonful 3 to 4 times daily.
Adults: 4-8 teaspoonful 3 to 4 times daily.

Suppository:

Children 3-12 months: 60-120 mg,4 times daily.
Children 1-5 years: 125-250 mg 4 times daily.
Children 6-12 years: 250-500 mg 4 times daily.
Adults & children over 12 years: 0.5-1 gm 4 times daily.

Paediatric Drop:

Children Upto 3 months: 0.5 ml (40 mg)
4 to 11 months: 1.0 ml (80 mg)
7 to 2 years: 1.5 ml (120 mg). Do not exceed more than 5 dose daily for a maximum of 5 days.

Paracetamol tablet with actizorb technology: It dissolves up to five times faster than standard Paracetamol tablets. It is a fast acting and safe analgesic with marked antipyretic property. It is specially suitable for patients who, for any reason, can not tolerate aspirin or other analgesics.

Adults and children (aged 12 years and over): Take 1 to 2 Tablets every four to six hours as needed. Do not take more than 8 caplets in 24 hours.
Children (7 to 11 years): Take ½-1 Tablet every four to six hours as needed. Do not take more than 4 caplets in 24 hours. Not recommended in children under 7 years.

Side effectsView

Side effects of paracetamol are usually mild, though haematological reactions including thrombocytopenia, leucopenia, pancytopenia, neutropenia, and agranulocytosis have been reported. Pancreatitis, skin rashes, and other allergic reactions occur occasionally.

ContraindicationsView

It is contraindicated in known hypersensitivity to Paracetamol.

PrecautionsView

Paracetamol should be given with caution to patients with impaired kidney or liver function. Paracetamol should be given with care to patients taking other drugs that affect the liver.

InteractionsView

Patients who have taken barbiturates, tricyclic antidepressants and alcohol may show diminished ability to metabolise large doses of Paracetamol. Alcohol can increase the hepatotoxicity of Paracetamol overdosage. Chronic ingestion of anticonvulsants or oral steroid contraceptives induce liver enzymes and may prevent attainment of therapeutic Paracetamol levels by increasing first-pass metabolism or clearance.

Pregnancy & lactationView

Pregnancy category B according to USFDA. This drug should be used during pregnancy only if clearly needed

Overdose effectsView

Symptoms of Paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12-48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur.

StorageView

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

SB-Opa Plus

Paracetamol + Caffeine

Tablet 500 mg+65 mg Allopathic Non opioid analgesics

Indications

Toothache

Indication detailsView

The is indicated in the following condition-

Headache
Migraine
Toothache
Neuralgia
Feverishness
Period pain
Sore throat
Backache
Help to reduce the temperature
Aches and pain of colds and flu

Therapeutic classView

Non opioid analgesics

PharmacologyView

This is a combination of Paracetamol and Caffeine. Paracetamol has analgesic and antipyretic properties with weak anti-inflammatory activity. Caffeine is an alkaloid which is a theophylline-like xanthine derivative. By intermolecular association with Paracetamol, Caffeine increases the solubility and transmembrane permeation of Paracetamol. In addition, Caffeine increases the pain threshold and tolerance of pain. Caffeine has also an intrinsic power to raise vessel tone in the brain, which provides another benefit to treat migraine and headache.

DosageView

Adult dose: 1-2 tablets every 4-6 hours. Maximum dose: 8 tablets daily.
Child dose: Not recommended for children below 12 years.

Side effectsView

Side effects of paracetamol are usually mild, though haematological reactions including thrombocytopenia, leukopenia, pancytopenia, neutropenia, and agranulocytosis have been reported. Pancreatitis, skin rashes, and other allergic reactions occur occasionally.

ContraindicationsView

Paracetamol is contraindicated in patients with severe renal function impairment and hepatic disease (Viral Hepatitis). Known hypersensitivity to paracetamol or caffeine.

PrecautionsView

Paracetamol & Caffeine should be given cautiously in the following cases: In patients with hepatic or renal failure, in patients taking other hepatotoxic medication. Prolonged use of the drug without consulting a physician should be avoided.

InteractionsView

May reduce serum levels with anticonvulsants (e.g. phenytoin, barbiturates, carbamazepine). May enhance the anticoagulant effect of warfarin and other coumarins with prolonged use. Accelerated absorption with metoclopramide and domperidone. May increase serum levels with probenecid. May increase serum levels of chloramphenicol. May reduce absorption with colestyramine within 1 hr of admin. May cause severe hypothermia with phenothiazine.

Pregnancy & lactationView

Pregnant mothers should consult with doctors before taking Paracetamol & Caffeine. Paracetamol & Caffeine can be taken whilst breast feeding.

Overdose effectsView

Symptoms of Paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 40 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur.

StorageView

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

SB-Quik

Ciprofloxacin

Tablet 500 mg Allopathic Anti-diarrhoeal Antimicrobial drugs

Indications

Urinary tract infection

Indication detailsView

Ciprofloxacin is indicated for the treatment of Respiratory Tract Infections,Urinary tract infections, Pelvic Inflammatory Diseases, Infectious Diarrhea (Shigella dysenteriae, Vibrio cholera), Typhoid fever, Intra-abdominal infections, Prostatitis, Skin and Soft Tissue Infections, Bone and Joint Infections, Gonorrhea, Neutropenic patients with fever due to bacterial infection, Meningitis, Surgical prophylaxis.

Therapeutic classView

4-Quinolone preparations, Anti-diarrhoeal Antimicrobial drugs

PharmacologyView

Ciprofloxacin is a synthetic fluoroquinolone. It has bactericidal activity against a wide range of gram-positive and gram-negative organisms. It inhibits bacterial DNA synthesis by binding with the bacterial enzyme-DNA gyrase and topoisomerase IV which are responsible for DNA supercoiling.

DosageView

Tablet: Adult:

Respiratory Tract Infections: 500 to 750 mg twice daily (7 to 14 days)
Urinary tract infections: 250 to 750 mg twice daily (3 to 10 days)
Pelvic Inflammatory Diseases: 500 to 750 mg twice daily (14 days)
Infectious Diarrhea (Shigella dysenteriae, Vibrio cholera): 500 mg twice daily (1 to 5 days)
Typhoid fever: 500 mg twice daily (7 days)
Intra-abdominal infections: 500 to 750 mg twice daily (5 to 14 days)
Prostatitis: 500 to 750 mg twice daily (2 to 6 weeks)
Skin and Soft Tissue Infections: 500 to 750 mg twice daily (7 to 14 days)
Bone and Joint Infections: 500 to 750 mg twice daily (max. 3 months)
Gonorrhea: 500 mg as a single dose
Neutropenic patients with fever due to bacterial infection: 500 to 750 mg twice daily co-administered with appropriate antibacterials.
Meningitis: 500 mg as a single dose.
Surgical prophylaxis: 500 mg as a single dose, 60 minutes before the procedure.

Suspension: Pediatric: 10-20 mg/kg (max. 750 mg) twice daily (10 to 21 days). The duration of therapy depends on the type and severity of the infection.

Extended-release tablet: In uncomplicated urinary tract infection (acute cystitis), the recommended dose of extended-release tablet is 1000 mg tablet once daily for three days.

For IV infusion:

Urinary Tract Infection: Mild to Moderate: 200 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 12 hourly for 7-14 days
Lower Respiratory Tract infection: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
Nosocomial Pneumonia: Mild/Moderate/Severe: 400 mg 8 hourly for 10-14 days
Skin and Skin Structure: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
Bone and Joint Infection: Mild to Moderate: 400 mg 12 hourly for more than 4-6 weeks; Severe/Complicated: 400 mg 8 hourly for more than 4-6weeks
Intraabdominal (Acute abdomen): Complicated: 400 mg 12 hourly for 7-14 days
Acute Sinusitis: Mild/Moderate: 400 mg 12 hourly for 10 days
Chronic Bacterial Prostatitis: Mild/Moderate: 400 mg 12 hourly for 28 Days.

AdministrationView

Instruction for the use of Ciprofloxacin IV infusion-

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

Duration of treatment: The duration of treatment depends upon the severity of infection, clinical response and bacteriological findings. For acute infections the usual treatment period is 5 to 10 days. Generally treatment should be continued for 3 days after the signs and symptoms of the infection have been disappeared.

Side effectsView

Side effects include- nausea and other gastrointestinal disturbances, headache, dizziness, joint pain and skin rashes.

ContraindicationsView

It is contraindicated in patients who have known hypersensitivity to Ciprofloxacin or other quinolones.

PrecautionsView

Patients receiving Ciprofloxacin should be instructed to drink fluids liberally. It should be used with caution in patients with suspected or known CNS disorders such as epilepsy or other factors which predispose to seizures and convulsion. Avoid in patients with known QT prolongation, hypokalemia.

InteractionsView

Concurrent administration of Ciprofloxacin should be avoided with Magnesium or Aluminum containing antacids or sucralfate or with other products containing Calcium, Iron or Zinc. These products may be taken two hours after or six hours before Ciprofloxacin. Ciprofloxacin should not be taken concurrently with milk or other dairy products, since absorption of Ciprofloxacin may be significantly reduced. Dietary calcium is a part of a meal, however, does not significantly affect the absorption of Ciprofloxacin.

Pregnancy & lactationView

There are no adequate and well-controlled studies in pregnant women. Ciprofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and mother. Ciprofloxacin is excreted in human milk. Due to the potential risk of articular damage, Ciprofloxacin should not be used during lactation.

Pediatric usageView

Although effective in clinical trials, Ciprofloxacin is not a drug of first choice in pediatric population.

Overdose effectsView

Overdose following Ciprofloxacin administration may lead to seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria, haematuria, & reversible renal toxicity.

StorageView

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

SB-Rabec

Rabeprazole Sodium

Tablet (Enteric Coated) 20 mg Allopathic Proton Pump Inhibitor

Indications

Gastric ulcer

Indication detailsView

Rabeprazole Gastro-resistant tablets are indicated for the treatment of:

Active duodenal ulcer
Active benign gastric ulcer
Symptomatic erosive or ulcerative gastro-esophageal reflux disease (GERD).
Gastro-esophageal Reflux Disease Long-term Management (GERD Maintenance)
Symptomatic treatment of moderate to very severe gastro-esophageal reflux disease (symptomatic GERD)
Zollinger-Ellison Syndrome
In combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori in patients with peptic ulcer disease.

Therapeutic classView

Proton Pump Inhibitor

PharmacologyView

Rabeprazole suppresses gastric acid secretion by inhibiting the gastric H⁺/K⁺-ATPase at the secretory surface of the gastric parietal cell. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, Rabeprazole has been characterized as a gastric proton-pump inhibitor.

DosageView

Active Duodenal Ulcer and Active Benign Gastric Ulcer: The recommended oral dose for both bioactive duodenal ulcer and active benign gastric ulcer is 20 mg to be taken once daily in the morning. Most patients with active duodenal ulcer heal within four weeks. However, a few patients may require an additional four weeks of therapy to achieve healing. Most patients with active benign gastric ulcer heal within six weeks. However, again a few patients may require an additional six weeks of therapy to achieve healing.

Erosive or Ulcerative Gastro-Esophageal Reflux Disease (GERD): The recommended oral dose for this condition is 20 mg to be taken once daily for four to eight weeks.

Gastro-Esophageal Reflux Disease Long-term Management (GERD Maintenance): For long-term management, a maintenance dose of rabeprazole sodium 20 mg or 10 mg once daily can be used depending upon patient response.

Symptomatic treatment of moderate to very severe Gastro-Esophageal Reflux Disease (symptomatic GERD): 10 mg once daily in patients without oesophagitis. If symptom control has not been achieved during four weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using an on-demand regimen taking 10 mg once daily when needed.

Treatment of GERD in pediatric patients 1 to 11 years of age (Less than 15 kg): 5 mg once daily for 12 weeks with the option to increase to 10 mg if inadequate response.

Treatment of GERD in pediatric patients 1 to 11 years of age (15 kg or more): 10 mg once daily for 12 weeks.

Zollinger-Ellison Syndrome: The recommended adult starting dose is 60 mg once a day. The dose may be titrated upwards to 120 mg/day based on individual patient needs. Single daily doses up to 100 mg/day may be given. 120 mg dose may require divided doses, 60 mg twice daily. Treatment should continue for as long as clinically indicated.

Eradication of H. pylori: Patients with H. pylori infection should be treated with eradication therapy. The following combination given for 7 days is recommended. Rabeprazole sodium 20 mg twice daily, clarithromycin 500 mg twice daily and amoxicillin 1g twice daily.

AdministrationView

For indications requiring once-daily treatment Rabeprazole tablets should be taken in the morning, before eating; and although neither the time of day nor food intake was shown to have any effect on rabeprazole sodium activity, this regimen will facilitate treatment compliance. Patients should be cautioned that the Rabeprazole tablets should not be chewed or crushed, but should be swallowed whole.

Side effectsView

In general, Rabeprazole is well-tolerated in both short-term and long-term studies. Rabeprazole may sometimes cause headache, diarrhoea, abdominal pain, vomiting, constipation, dry mouth, increased or decreased appetite, muscle pain, drowsiness, dizziness.

ContraindicationsView

Hypersensitivity to the active substance or to any of the excipients. Rabeprazole is contra-indicated in pregnancy and during breastfeeding.

PrecautionsView

Symptomatic response to therapy with Rabeprazole does not preclude the presence of gastric or oesophageal malignancy, therefore the possibility of malignancy should be excluded prior to commencing treatment with Rabeprazole 20 mg Gastro-resistant Tablets.
Patients on long-term treatment (particularly those treated for more than a year) should be kept under regular surveillance.
Proton pump inhibitors, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognised risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10–40%. Some of this increase may be due to other risk factors. Patients at risk of osteoporosis should receive care and they should have an adequate intake of vitamin D and calcium.
A risk of cross-hypersensitivity reactions with other proton pump inhibitor or substituted benzimidazoles cannot be excluded.
Patients should be cautioned that Rabeprazole gastro-resistant tablets should not be chewed or crushed, but should be swallowed whole.
There have been post marketing reports of blood dyscrasias (thrombocytopenia and neutropenia). In the majority of cases where an alternative aetiology cannot be identified, the events were uncomplicated and resolved on discontinuation of rabeprazole.
Hepatic enzyme abnormalities have been seen in clinical trials and have also been reported since market authorisation. In the majority of cases where an alternative aetiology cannot be identified, the events were uncomplicated and resolved on discontinuation of rabeprazole.
No evidence of significant drug related safety problems was seen in a study of patients with mild to moderate hepatic impairment versus normal age and sex matched controls. However because there are no clinical data on the use of rabeprazole in the treatment of patients with severe hepatic dysfunction the prescriber is advised to exercise caution when treatment with Rabeprazole 20mg Gastro-resistant. Tablets is first initiated in such patients.
Co-administration of atazanavir with Rabeprazole is not recommended.
Treatment with proton pump inhibitors, including rabeprazole, may possibly increase the risk of gastrointestinal infections such as Salmonella, Campylobacter and Clostridium difficile.

Hypomagnesaemia: Severe hypomagnesaemia has been reported in patients treated with PPIs like rabeprazole for at least three months, and in most cases for a year. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia can occur but they may begin insidiously and be overlooked. In most affected patients, hypomagnesaemia improved after magnesium replacement and discontinuation of the PPI. For patients expected to be on prolonged treatment or who take PPIs with digoxin or drugs that may cause hypomagnesaemia (e.g., diuretics), health care professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.

Influence on vitamin B12 absorption: Rabeprazole sodium, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or a- chlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy or if respective clinical symptoms are observed.

Subacute cutaneous lupus erythematosus (SCLE): Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping Rabeprazole. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.

Interference with laboratory tests: Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, Rabeprazole 20mg Gastro-resistant Tablets treatment should be stopped for at least 5 days before CgA measurements. If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment.

InteractionsView

Respite produces a profound and long-lasting inhibition of gastric acid secretion. An interaction with a compound whose absorption is pH dependent may occur. Co-administration of rabeprazole sodium with ketoconazole or itraconazole may result in a significant decrease in antifungal plasma levels. Therefore individual patients may need to be monitored to determine if a dosage adjustment is necessary when ketoconazole or itraconazole are taken concomitantly with Respite. No interaction with liquid antacids was observed. The absorption of atazanavir is pH-dependent. Therefore PPIs, including rabeprazole, should not be co-administered with atazanavir.

Pregnancy & lactationView

US FDA pregnancy category 'C'. Studies have been performed in animals and have revealed no evidence of impaired fertility or harm to the fetus due to Rabeprazole. There are however, no adequate and well-controlled studies in pregnant women. Rabeprazole is likely to be excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric usageView

Renal and hepatic impairment: No dosage adjustment is necessary for patients with renal or hepatic impairment.

Pediatric populations: Rabeprazole is not recommended for use in children due to a lack of data on safety and efficacy.

Overdose effectsView

The maximum established exposure has not exceeded 60 mg twice daily, or 160 mg once daily. Effects are generally minimal, representative of the known adverse event profile and reversible without further medical intervention. No specific antidote is known. Rabeprazole is extensively protein bound and is, therefore, not dialysable. As in any case of overdose, treatment should be symptomatic and general supportive measures should be utilised.

StorageView

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

SB-Rostin

Rosuvastatin

Tablet 10 mg Allopathic Other Anti-anginal & Anti-ischaemic drugs

Indications

Stroke

Indication detailsView

Rosuvastatin is indicated in-

Heterozygous Hypercholesterolemia (Familial and Non familial)
Homozygous Hypercholesterolemia (Familial)
Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
Primary prevention of cardiovascular disease

Therapeutic classView

Other Anti-anginal & Anti-ischaemic drugs, Statins

PharmacologyView

Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.

DosageView

Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg

HoFH: Starting dose 20 mg/day.

Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.

Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.

AdministrationView

Rosuvastatin can be taken with or without food, at any time of day.

Side effectsView

Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.

ContraindicationsView

Rosuvastatin is contraindicated if-

Known hypersensitivity to product components
Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
Pregnant women and women who may become pregnant
Nursing mothers

PrecautionsView

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.

Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.

Liver enzymes should be monitored before and during treatment

InteractionsView

Remarkable drug interactions of Rosuvastatin are-

Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily.
Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily.
Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily.
Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy.
Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.

Pregnancy & lactationView

The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.

Pediatric usageView

Use in children: The safety and effectiveness in pediatric patients have not been established.

StorageView

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

SB-Rostin

Rosuvastatin

Tablet 20 mg Allopathic Other Anti-anginal & Anti-ischaemic drugs

Indications

Stroke

Indication detailsView

Rosuvastatin is indicated in-

Heterozygous Hypercholesterolemia (Familial and Non familial)
Homozygous Hypercholesterolemia (Familial)
Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
Primary prevention of cardiovascular disease

Therapeutic classView

Other Anti-anginal & Anti-ischaemic drugs, Statins

PharmacologyView

Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.

DosageView

Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg

HoFH: Starting dose 20 mg/day.

Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.

Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.

AdministrationView

Rosuvastatin can be taken with or without food, at any time of day.

Side effectsView

Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.

ContraindicationsView

Rosuvastatin is contraindicated if-

Known hypersensitivity to product components
Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
Pregnant women and women who may become pregnant
Nursing mothers

PrecautionsView

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.

Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.

Liver enzymes should be monitored before and during treatment

InteractionsView

Remarkable drug interactions of Rosuvastatin are-

Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily.
Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily.
Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily.
Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy.
Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.

Pregnancy & lactationView

The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.

Pediatric usageView

Use in children: The safety and effectiveness in pediatric patients have not been established.

StorageView

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

SB-Serta

Sertraline Hydrochloride

Tablet 50 mg Allopathic SSRIs & related anti-depressant drugs

Indications

Trichotillomania

Indication detailsView

Sertraline is indicated for the treatment of-

Major depressive disorder (MDD)
Obsessive-compulsive disorder (OCD)
Panic disorder (PD)
Post-traumatic stress disorder (PTSD)
Social anxiety disorder (SAD)
Premenstrual dysphoric disorder (PMDD).

Therapeutic classView

SSRIs & related anti-depressant drugs

PharmacologyView

Sertraline has potent and selective inhibitory action on CNS neuronal reuptake of 5-HT resulting in increased 5-HT concentrations at the synaptic clefts, leading to facilitation of its sustained activity at the postsynaptic receptor sites. It ultimately results in an improvement of depression. Reduction of Serotonin turnover in brain by Sertraline is also another contributing fact implicated in its action. Its prolonged elimination half-life offers a benefit of once daily administration.

DosageView

Adults-
Major depressive disorder:

Starting Dose: 50 mg
Therapeutic Range: 50-200 mg

Obsessive-compulsive disorder:

Starting Dose: 50 mg
Therapeutic Range: 50-200 mg

Panic disorder, Post-traumatic stress disorder, Social anxiety disorder:

Starting Dose: 25 mg
Therapeutic Range: 50-200 mg

Pediatric Patients (ages 6-12 years old)-
Obsessive-compulsive disorder:

Starting Dose: 25 mg
Therapeutic Range: 50-200 mg

The recommended interval between dose changes is one week.

Premenstrual dysphoric disorder (PMDD): Starting dosage for PMDD is 50 mg/day. Sertraline may be administered either continuously (every day throughout the menstrual cycle) or intermittently (starting the daily dosage 14 days prior to the anticipated onset of menstruation and continuing through the onset of menses). Intermittent dosing would be repeated with each new cycle.

Continuous: Patients not responding to a 50 mg dosage may benefit from dosage increases at 50 mg increments per menstrual cycle up to 150 mg per day.
Intermittent: Patients not responding to a 50 mg dosage may benefit from increasing the dosage up to a maximum of 100 mg per day during the next menstrual cycle (and subsequent cycles).

Side effectsView

Sertraline may cause side effects like upset stomach, diarrhoea, constipation, vomiting, dry mouth, loss of appetite, weight changes, drowsiness, dizziness, headache, pain, burning or tingling in the hands or feet, excitement, sore throat etc.

ContraindicationsView

Sertraline is contraindicated in patients with a known hypersensitivity to Sertraline or any of the excipients of drug. In patients with moderate to severe hepatic impairment is not recommended.

PrecautionsView

Precaution should be taken in case of liver problems, kidney diseases, seizures, heart problems and any allergies. This drug may cause dizziness or drowsiness. Caution should be taken in activities requiring alertness such as driving or using machinery. Caution is advised while using this product in the elderly because they may be more sensitive to the effects of the drug. Do not take this drug if you have taken monoamine oxidase inhibitor in the last five weeks. Risk of suicidal thinking and change of behavior may occur (close monitoring of the patient after 2 to 3 weeks of use is required).

InteractionsView

Potential effects of co-administration of drugs that are highly bound to plasma proteins- As Sertraline is tightly bound to plasma protein, the administration of Sertraline to a patient taking another drug which is tightly bound to protein, (e.g. warfarin, digitoxin) may cause a shift in plasma concentrations potentially resulting in an adverse effect. Conversely adverse effects may result from displacement of protein bound Sertraline by other tightly bound drugs. Sertraline may interact with other drugs such as Cimetidine, CNS active drugs like Diazepam, Hypoglycemic drugs, Atenolol etc.

Pregnancy & lactationView

Although animal studies did not provide any evidence of teratogenicity, the safety of Sertraline during human pregnancy has not been established. Sertraline is known to be excreted in breast milk. Its effects on the nursing infant have not yet been established. If treatment with Sertraline is considered necessary, discontinuation of breast-feeding should be considered.

StorageView

Do not store above 30°C. Keep out of the reach of children.

SB-Sild

Sildenafil Citrate

Tablet 100 mg Allopathic Drugs for Erectile Dysfunction

Indications

Pulmonary arterial hypertension

Indication detailsView

Sildenafil is indicated for the treatment of erectile dysfunction.

Therapeutic classView

Drugs for Erectile Dysfunction

PharmacologyView

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.

DosageView

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.

AdministrationView

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

Side effectsView

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

ContraindicationsView

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.

PrecautionsView

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.

InteractionsView

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 & lactationView

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.

StorageView

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

SB-Sild

Sildenafil Citrate

Tablet 50 mg Allopathic Drugs for Erectile Dysfunction

Indications

Pulmonary arterial hypertension

Indication detailsView

Sildenafil is indicated for the treatment of erectile dysfunction.

Therapeutic classView

Drugs for Erectile Dysfunction

PharmacologyView

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.

DosageView

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.

AdministrationView

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

Side effectsView

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

ContraindicationsView

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.

PrecautionsView

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.

InteractionsView

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 & lactationView

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.

StorageView

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

SB-Sita

Sitagliptin

Tablet 100 mg Allopathic Dipeptidyl Peptidase-4 (DPP-4) inhibitor

Indications

Type 2 DM

Indication detailsView

Monotherapy and Combination Therapy: Sitagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Important Limitations of Use: Sitagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. Sitagliptin has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using Sitagliptin.

Therapeutic classView

Dipeptidyl Peptidase-4 (DPP-4) inhibitor

PharmacologyView

Sitagliptin is a DPP-4 inhibitor, which is believed to exert its actions in patients with type 2 diabetes by slowing the inactivation of incretin hormones. Concentrations of the active intact hormones are increased by Sitagliptin, thereby increasing and prolonging the action of these hormones. Incretin hormones, including glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), are released by the intestine throughout the day, and levels are increased in response to a meal. These hormones are rapidly inactivated by the enzyme, DPP-4. The incretins are part of an endogenous system involved in the physiologic regulation of glucose homeostasis. When blood glucose concentrations are normal or elevated, GLP-1 and GIP increase insulin synthesis and release from pancreatic beta cells by intracellular signaling pathways involving cyclic AMP. GLP-1 also lowers glucagon secretion from pancreatic alpha cells, leading to reduced hepatic glucose production. By increasing and prolonging active incretin levels, Sitagliptin increases insulin release and decreases glucagon levels in the circulation in a glucose-dependent manner. Sitagliptin demonstrates selectivity for DPP-4 and does not inhibit DPP-8 or DPP-9 activity in vitro at concentrations approximating those from therapeutic doses.

DosageView

The recommended dose of sitagliptin is 50 mg twice a day and 100 mg once daily. Sitagliptin can be taken with or without food.

Side effectsView

The most common adverse reactions include headache, upper respiratory tract infection and nasopharyngitis. Hypoglycemia may occur in patients treated with the combination to Sitagliptin and sulfonylurea and add on to insulin.

ContraindicationsView

History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema.

PrecautionsView

If pancreatitis is suspected, sitagliptin should promptly be discontinued and appropriate management should be initiated.

Use in Patients with Renal Insufficiency: Dosage adjustment is recommended in patients with moderate or severe renal insufficiency and in patients with ESRD requiring hemodialysis or peritoneal dialysis.

Use with medications known to cause Hypoglycemia: When sitagliptin is used in combination therapy dosage adjustment of sulfonylurea or insulin may be required to reduce the risk of hypoglycemia.

Hypersensitivity Reactions: There have been post-marketing reports of serious hypersensitivity reactions in patients treated with sitagliptin. These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. If a hypersensitivity reaction is suspected, discontinue sitagliptin, assess for other potential causes for the event, and institute alternative treatment for diabetes.

InteractionsView

Effects of sitagliptin on other Drugs: Sitagliptin did not meaningfully alter the pharmacokinetics of metformin, glyburide, simvastatin, rosiglitazone, warfarin, or oral contraceptive.

Digoxin: Sitagliptin slightly increases the mean of Digoxin concentration. However, no dose adjustment of either drug is required.

Pregnancy & lactationView

Pregnancy Category B. Reproduction studies have been performed in rats and rabbits. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Sitagliptin is secreted in the milk of lactating rats at milk to plasma ratio of 4:1. It is not known whether sitagliptin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when sitagliptin is administered to a nursing woman.

Pediatric usageView

Pediatric Use: Safety and effectiveness of sitagliptin in pediatric patients under 18 years of age have not been established.

Geriatric Use: This drug is known to be substantially excreted by the kidney. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in the elderly, and it may be useful to assess renal function in these patients prior to initiating dosing and periodically thereafter.

For patients with mild renal insufciency: (CrCl <50 ml/min or serum creatinine levels of <1.7 mg/DL in men and <1.5 mg/DL in women), no dosage adjustment for sitagliptin is required.

For patients with moderate renal insufciency: (CrCl <30 to <50 mL/min, or serum creatinine levels of >1.7 to <3.0 mg/dL in men and >1.5 to <2.5 mg/dL in women), the dose of sitagliptin is 50 mg once daily.

For patients with severe renal insufficiency: (CrCl <30 mL/min or serum creatinine levels of >3.0 mg/dL in men and 2.5 mg/dL in women) or with end-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis, the dose of sitagliptin is 25 mg once daily. Sitagliptin may be administered without regard to the limiting of hemodialysis.

Overdose effectsView

During controlled clinical trials in healthy subjects, single doses of up to 800 mg Sitagliptin were administered. Maximal mean increases in QTc of 8.0 msec were observed in one study at a dose of 800 mg Sitagliptin, a mean effect that is not considered clinically important. There is no experience with doses above 800 mg in clinical studies. In Phase I multiple-dose studies, there were no dose-related clinical adverse reactions observed with Sitagliptin with doses of up to 600 mg per day for periods of up to 10 days and 400 mg per day for up to 28 days.

In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring (including obtaining an electrocardiogram), and institute supportive therapy as dictated by the patient's clinical status. Sitagliptin is modestly dialyzable. In clinical studies, approximately 13.5% of the dose was removed over a 3- to 4-hour hemodialysis session. Prolonged hemodialysis may be considered if clinically appropriate. It is not known if sitagliptin is dialyzable by peritoneal dialysis.

StorageView

Store below 25°C in a dry place away from light. Keep the medicines in a safe place, out of the reach of children. Do not use later than the date of expiry. To be dispensed only on the prescription of a registered physician

SB-Sita

Sitagliptin

Tablet 50 mg Allopathic Dipeptidyl Peptidase-4 (DPP-4) inhibitor

Indications

Type 2 DM

Indication detailsView

Monotherapy and Combination Therapy: Sitagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Important Limitations of Use: Sitagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. Sitagliptin has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using Sitagliptin.

Therapeutic classView

Dipeptidyl Peptidase-4 (DPP-4) inhibitor

PharmacologyView

Sitagliptin is a DPP-4 inhibitor, which is believed to exert its actions in patients with type 2 diabetes by slowing the inactivation of incretin hormones. Concentrations of the active intact hormones are increased by Sitagliptin, thereby increasing and prolonging the action of these hormones. Incretin hormones, including glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), are released by the intestine throughout the day, and levels are increased in response to a meal. These hormones are rapidly inactivated by the enzyme, DPP-4. The incretins are part of an endogenous system involved in the physiologic regulation of glucose homeostasis. When blood glucose concentrations are normal or elevated, GLP-1 and GIP increase insulin synthesis and release from pancreatic beta cells by intracellular signaling pathways involving cyclic AMP. GLP-1 also lowers glucagon secretion from pancreatic alpha cells, leading to reduced hepatic glucose production. By increasing and prolonging active incretin levels, Sitagliptin increases insulin release and decreases glucagon levels in the circulation in a glucose-dependent manner. Sitagliptin demonstrates selectivity for DPP-4 and does not inhibit DPP-8 or DPP-9 activity in vitro at concentrations approximating those from therapeutic doses.

DosageView

The recommended dose of sitagliptin is 50 mg twice a day and 100 mg once daily. Sitagliptin can be taken with or without food.

Side effectsView

The most common adverse reactions include headache, upper respiratory tract infection and nasopharyngitis. Hypoglycemia may occur in patients treated with the combination to Sitagliptin and sulfonylurea and add on to insulin.

ContraindicationsView

History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema.

PrecautionsView

If pancreatitis is suspected, sitagliptin should promptly be discontinued and appropriate management should be initiated.

Use in Patients with Renal Insufficiency: Dosage adjustment is recommended in patients with moderate or severe renal insufficiency and in patients with ESRD requiring hemodialysis or peritoneal dialysis.

Use with medications known to cause Hypoglycemia: When sitagliptin is used in combination therapy dosage adjustment of sulfonylurea or insulin may be required to reduce the risk of hypoglycemia.

Hypersensitivity Reactions: There have been post-marketing reports of serious hypersensitivity reactions in patients treated with sitagliptin. These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. If a hypersensitivity reaction is suspected, discontinue sitagliptin, assess for other potential causes for the event, and institute alternative treatment for diabetes.

InteractionsView

Effects of sitagliptin on other Drugs: Sitagliptin did not meaningfully alter the pharmacokinetics of metformin, glyburide, simvastatin, rosiglitazone, warfarin, or oral contraceptive.

Digoxin: Sitagliptin slightly increases the mean of Digoxin concentration. However, no dose adjustment of either drug is required.

Pregnancy & lactationView

Pregnancy Category B. Reproduction studies have been performed in rats and rabbits. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Sitagliptin is secreted in the milk of lactating rats at milk to plasma ratio of 4:1. It is not known whether sitagliptin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when sitagliptin is administered to a nursing woman.

Pediatric usageView

Pediatric Use: Safety and effectiveness of sitagliptin in pediatric patients under 18 years of age have not been established.

Geriatric Use: This drug is known to be substantially excreted by the kidney. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in the elderly, and it may be useful to assess renal function in these patients prior to initiating dosing and periodically thereafter.

For patients with mild renal insufciency: (CrCl <50 ml/min or serum creatinine levels of <1.7 mg/DL in men and <1.5 mg/DL in women), no dosage adjustment for sitagliptin is required.

For patients with moderate renal insufciency: (CrCl <30 to <50 mL/min, or serum creatinine levels of >1.7 to <3.0 mg/dL in men and >1.5 to <2.5 mg/dL in women), the dose of sitagliptin is 50 mg once daily.

For patients with severe renal insufficiency: (CrCl <30 mL/min or serum creatinine levels of >3.0 mg/dL in men and 2.5 mg/dL in women) or with end-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis, the dose of sitagliptin is 25 mg once daily. Sitagliptin may be administered without regard to the limiting of hemodialysis.

Overdose effectsView

During controlled clinical trials in healthy subjects, single doses of up to 800 mg Sitagliptin were administered. Maximal mean increases in QTc of 8.0 msec were observed in one study at a dose of 800 mg Sitagliptin, a mean effect that is not considered clinically important. There is no experience with doses above 800 mg in clinical studies. In Phase I multiple-dose studies, there were no dose-related clinical adverse reactions observed with Sitagliptin with doses of up to 600 mg per day for periods of up to 10 days and 400 mg per day for up to 28 days.

In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring (including obtaining an electrocardiogram), and institute supportive therapy as dictated by the patient's clinical status. Sitagliptin is modestly dialyzable. In clinical studies, approximately 13.5% of the dose was removed over a 3- to 4-hour hemodialysis session. Prolonged hemodialysis may be considered if clinically appropriate. It is not known if sitagliptin is dialyzable by peritoneal dialysis.

StorageView

Store below 25°C in a dry place away from light. Keep the medicines in a safe place, out of the reach of children. Do not use later than the date of expiry. To be dispensed only on the prescription of a registered physician

SB-Sovir

Sofosbuvir

Tablet 400 mg Allopathic Hepatic viral infections (Hepatitis C)

Indications

Chronic hepatitis C

Indication detailsView

Sofosbuvir is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen.

Sofosbuvir efficacy has been established in subjects with HCV genotype 1, 2, 3 or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation) and those with HCV/HIV-1 co-infection.

The following points should be considered when initiating treatment with Sofosbuvir:

Monotherapy of Sofosbuvir is not recommended for treatment of CHC.
Treatment regimen and duration are dependent on both viral genotype and patient population.
Treatment response varies based on baseline host and viral factor.

Therapeutic classView

Hepatic viral infections (Hepatitis C)

PharmacologyView

Sofosbuvir is nucleotide analog inhibitor, which specifically inhibits HCV NS5B (non-structural protein 5B) RNA-dependent RNA polymerase. Following intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203), sofosbuvir incorporates into HCV RNA by the NS5B polymerase and acts as a chain terminator. More specifically, Sofosbuvir prevents HCV viral replication by binding to the two Mg2+ ions present in HCV NS5B polymerase's GDD active site motif and preventing further replication of HCV genetic material

DosageView

One 400 mg tablet taken once daily with or without food. Should be used in combination with Ribavirin or in combination with Pegylated Interferon and Ribavirin for the treatment of CHC.

Recommended combination therapy: (HCV Mono-infected and HCV/HIV-1 Co-infected)-

Genotype 1 or 4: Sofosbuvir + Peginterferon alfa + Ribavirin for 12 weeks
Genotype 2: Sofosbuvir + Ribavirin for 12 weeks
Genotype 3: Sofosbuvir + Ribavirin for 24 weeks

Sofosbuvir in combination with Ribavirin for 24 weeks can be considered for CHC patients with genotype 1 infection who are Interferon ineligible

Should be used in combination with Ribavirin for treatment of CHC in patients with hepatocellular carcinoma awaiting liver transplantation for up to 48 weeks or until liver transplantation whichever occurs first

A dose recommendation cannot be made for patients with severe renal impairment or end stage renal disease

Side effectsView

The most common adverse events (incidence greater than or equal to 20%, all grades) observed with Sofosbuvir in combination with Ribavirin were fatigue and headache. The most common adverse events observed with Sofosbuvir in combination with Peginterferon alfa and Ribavirin were fatigue, headache, nausea, insomnia, anemia, pruritus, asthenia, rash, decreased appetite, chills, influenza like illness, pyrexia, diarrhea, neutropenia, myalgia, irritability.

ContraindicationsView

When Sofosbivur is used in combination with Ribavirin or Peginterferon alfa/ Ribavirin, the contraindications applicable to those agents are applicable to combination therapies. Sofosbuvir combination treatment with Ribavirin or Peginterferon alfa/Ribavirin is contraindicated in women who are pregnant or may become pregnant and men whose female partners are pregnant, because of the risks for birth defects and fetal death associated with Ribavirin.

PrecautionsView

Bradycardia with amiodarone co-administration: Serious symptomatic bradycardia may occur in patients taking amiodarone and Sofosbuvir in combination with another direct acting antiviral (DAA), particularly in patients also receiving beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease. Co-administration of amiodarone with Sofosbuvir in combination with another DAA is not recommended. In patients without alternative, viable treatment options, cardiac monitoring is recommended.

InteractionsView

Reduced therapeutic effect with drugs that are potent P-gp inducers in the intestine (eg rifampicin, St. John's wort, carbamazepine & phenytoin), modafinil, phenobarb/ oxcarbazepine, rifabutin/ rifapentine. P-gp &/or BCRP inhibitors. May result in serious symptomatic bradycardia when co-administered with amiodarone in combination with another direct acting antiviral.

Pregnancy & lactationView

Pregnancy Category B: Sofosbuvir There are no adequate and well-controlled studies with Sofosbuvir in pregnant women.

Nursing Mothers: It is not known whether Sofosbuvir and its metabolites are present in human breast milk.

Pediatric usageView

Pediatric Use: Safety and effectiveness of Sofosbuvir in children less than 18 years of age have not been established.

Geriatric Use: Sofosbuvir was administered to 90 subjects aged 65 and over. The response rates observed for subjects over 65 years of age were similar to that of younger subjects across treatment groups. No dose adjustment of Sofosbuvir is warranted in geriatric patients.

Overdose effectsView

The highest dose of Sofosbuvir is a single dose of Sofosbuvir 1200 mg. No specific antidote is available for overdose treatment. Treatment of overdose with Sofosbuvir consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.

StorageView

Keep out of the reach of children. Keep in a cool & dry place. Protect from light.

SB-Tad

Tadalafil

Tablet 10 mg Allopathic Drugs for Erectile Dysfunction

Indications

Pulmonary arterial hypertension

Indication detailsView

Tadalafil is indicated in-

Erectile Dysfunction (ED)
Benign Prostatic Hyperplasia (BPH)
Both Erectile Dysfunction and signs and symptoms of Benign Prostatic Hyperplasia

Therapeutic classView

Drugs for Erectile Dysfunction

PharmacologyView

Tadalafil is a selective phosphodiesterase type 5 (PDE5) inhibitor. Inhibition of PDE5 increases cGMP in smooth muscle cells. cGMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum, causing penile erection. PDE5 also is present in smooth muscles of the prostate and bladder wall. Inhibiting PDE5 increases cGMP concentrations leading to relaxation of smooth muscle in the prostate and bladder. Smooth muscle relaxation may improve blood flow to the urinary tract and widen the opening of the bladder neck, resulting in improved voiding.

DosageView

Erectile Dysfunction: For most patients the recommended starting dose is 10 mg. The dose may be increased to 20 mg or decreased to 5 mg based on requirement. The maximum dosing frequency is once daily. Tadalafil is effective for up to 36 hours.

Benign prostatic hyperplasia: The recommended dose is 5 mg taken at the same time every day.

Combined Erectile Dysfunction and Benign prostatic hyperplasia: The recommended dose is 5 mg at the same time every day.

Side effectsView

Headache, Dyspepsia, Back pain, Myalgia, Nasal pharyngitis, Nasal congestion are common side effects. Change in Color Vision, Sudden vision loss, Hearing loss, Stevens-Johnson Syndrome, Exfoliative dermatitis, Angina, Stroke, Myocardial infarction, Severe hypotension, Tachycardia may also occur rarely.

ContraindicationsView

Use of Nitrates (for example, Nitroglycerine, Isosorbide): may increase hypotensive effects of Nitrates
Hypersensitivity reactions to Tadalafil

PrecautionsView

Angina, renal impairment, hepatic impairment, bleeding concomitant with Nitrates, Alpha Blockers, Alcohol, CYP3A4 Inhibitors (for example, Ritonavir, Ketoconazole, Itraconazole), other PDE5 inhibitors precaution should be taken in all these conditions.

InteractionsView

May interact with Nitrates for example, Isosorbide, Nitroglycerin, Alpha adrenergic blockers, Antihypertensives, Alcohol, Antacids (magnesuim hydroxide/aluminum hydroxide), Ketoconazole, Ritonavir, Erythromycin, Itraconazole, Grapefruit juice, other HIV protease inhibitors, Rifampin, Carbamazepine, Phenytoin & Phenobarbital.

Pregnancy & lactationView

Tadalafil has been assigned to pregnancy category B by the USFDA. Tadalafil is only recommended for use during pregnancy when benefit outweighs risk. There are no data on the excretion of Tadalafil in human milk. Caution should be used when administering tadalafil to nursing women.

StorageView

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

SB-Tad

Tadalafil

Tablet 5 mg Allopathic Drugs for Erectile Dysfunction

Indications

Pulmonary arterial hypertension

Indication detailsView

Tadalafil is indicated in-

Erectile Dysfunction (ED)
Benign Prostatic Hyperplasia (BPH)
Both Erectile Dysfunction and signs and symptoms of Benign Prostatic Hyperplasia

Therapeutic classView

Drugs for Erectile Dysfunction

PharmacologyView

Tadalafil is a selective phosphodiesterase type 5 (PDE5) inhibitor. Inhibition of PDE5 increases cGMP in smooth muscle cells. cGMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum, causing penile erection. PDE5 also is present in smooth muscles of the prostate and bladder wall. Inhibiting PDE5 increases cGMP concentrations leading to relaxation of smooth muscle in the prostate and bladder. Smooth muscle relaxation may improve blood flow to the urinary tract and widen the opening of the bladder neck, resulting in improved voiding.

DosageView

Erectile Dysfunction: For most patients the recommended starting dose is 10 mg. The dose may be increased to 20 mg or decreased to 5 mg based on requirement. The maximum dosing frequency is once daily. Tadalafil is effective for up to 36 hours.

Benign prostatic hyperplasia: The recommended dose is 5 mg taken at the same time every day.

Combined Erectile Dysfunction and Benign prostatic hyperplasia: The recommended dose is 5 mg at the same time every day.

Side effectsView

Headache, Dyspepsia, Back pain, Myalgia, Nasal pharyngitis, Nasal congestion are common side effects. Change in Color Vision, Sudden vision loss, Hearing loss, Stevens-Johnson Syndrome, Exfoliative dermatitis, Angina, Stroke, Myocardial infarction, Severe hypotension, Tachycardia may also occur rarely.

ContraindicationsView

Use of Nitrates (for example, Nitroglycerine, Isosorbide): may increase hypotensive effects of Nitrates
Hypersensitivity reactions to Tadalafil

PrecautionsView

Angina, renal impairment, hepatic impairment, bleeding concomitant with Nitrates, Alpha Blockers, Alcohol, CYP3A4 Inhibitors (for example, Ritonavir, Ketoconazole, Itraconazole), other PDE5 inhibitors precaution should be taken in all these conditions.

InteractionsView

May interact with Nitrates for example, Isosorbide, Nitroglycerin, Alpha adrenergic blockers, Antihypertensives, Alcohol, Antacids (magnesuim hydroxide/aluminum hydroxide), Ketoconazole, Ritonavir, Erythromycin, Itraconazole, Grapefruit juice, other HIV protease inhibitors, Rifampin, Carbamazepine, Phenytoin & Phenobarbital.

Pregnancy & lactationView

Tadalafil has been assigned to pregnancy category B by the USFDA. Tadalafil is only recommended for use during pregnancy when benefit outweighs risk. There are no data on the excretion of Tadalafil in human milk. Caution should be used when administering tadalafil to nursing women.

StorageView

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

SB-Vilda

Vildagliptin

Tablet 50 mg Allopathic Dipeptidyl Peptidase-4 (DPP-4) inhibitor

Indications

Type 2 DM

Indication detailsView

Vildagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus as monotherapy and in dual combination with Metformin, a Sulphonylurea, a Thiazolidinedione, or Insulin when diet, exercise and a single antidiabetic agent do not result in adequate glycemic control.

Therapeutic classView

Dipeptidyl Peptidase-4 (DPP-4) inhibitor

PharmacologyView

Vildagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor, which is believed to exert its actions in patients with type 2 diabetes by slowing the inactivation of incretin hormones. Incretin hormones, including glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), are released by the intestine throughout the day, and levels are increased in response to a meal. These hormones are rapidly inactivated by the enzyme, DPP-4. The incretins are part of an endogenous system involved in the physiologic regulation of glucose homeostasis. When blood glucose concentrations are normal or elevated, GLP-1 and GIP increase insulin synthesis and release from pancreatic beta cells by intracellular signaling pathways involving cyclic AMP. GLP-1 also lowers glucagon secretion from pancreatic alpha cells, leading to reduced hepatic glucose production. By increasing and prolonging active incretin levels, Vildagliptin increases insulin release and decreases glucagon levels in the circulation in a glucose-dependent manner.

DosageView

The recommended dose of Vildagliptin is-

50 mg or 100 mg daily for monotherapy.
50 mg twice daily (morning and evening) when used in dual combination with Metformin or a Thiazolidinedione;
50 mg once daily in the morning when used in dual combination with a Sulphonylurea.

Vildagliptin may be taken with or without a meal. No dosage adjustment is required in the elderly, or in patients with mild renal impairment.

Pediatric use: Vildagliptin is not recommended in patients 18 years of age.

Side effectsView

The majority of adverse reactions were mild and transient, not requiring treatment discontinuations. A rare case of hepatic dysfunction is seen. Clinical trials of up to and more than 2 years duration did not show any additional safety signals or unforeseen risks when using this combination.

ContraindicationsView

Vildagliptin is contraindicated in patients with:

Hypersensitivity to the active substance or to any of the excipients
Patients with moderate to severe renalImpairment
Patients with Hepatic Impairment: patients with pre-treatment alanine aminotransferase (ALT) or aspartate aminotrasferase (AST) >3 times the upper limit of normal (ULN).
Patients with type 1 diabetes

PrecautionsView

Caution should be exercised in patients aged 75 years and older due to limited clinical experience. It is recommended that LFTs are monitored prior to initiation of Vildagliptin, at three-monthly intervals in the first year and periodically thereafter. If transaminase levels are increased, patients should be monitored with a second liver function evaluation to confirm the finding and be followed thereafter with frequent liver function tests until the abnormality returns to normal. If AST or ALT persists at 3xULN, Vildagliptin treatment should be stopped. Patients who develop jaundice or other signs of liver dysfunction should discontinue Vildagliptin. Following the withdrawal of treatment with Vildagliptin and LFT normalization, treatment with Vildagliptin should not be reinitiated. Due to limited clinical experience, use with caution in patients with congestive heart failure of New York Heart Association (NYHA) functional class I-II, and do not use in patients with NYHA functional class III IV.

InteractionsView

In pharmacokinetic studies, no interactions were seen with pioglitazone, metformin, glibenclamide, digoxin, warfarin, amlodipine, ramipril, valsartan or simvastatin. As with other oral antidiabetic medicinal products the glucose-lowering effect of Vildagliptin may be reduced by certain active substances, including thiazides, corticosteroids, thyroid products and sympathomimetics.

Pregnancy & lactationView

Vildagliptin should not be used in pregnancy. Vildagliptin should not be used during lactation.

StorageView

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