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Wednesday, 09 March 2016 19:13

P-lock

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P-lock

Pantoprazole

 

Presentation

P-lock 20 tablet: Each delayed release tablet contains Pantoprazole Sodium Sesquihydrate USP equivalent to Pantoprazole 20 mg.

P-lock 40 tablet: Each delayed release tablet contains Pantoprazole Sodium Sesquihydrate USP equivalent to Pantoprazole 40 mg.

 

Description

Pantoprazole (P-lock) is chemically a novel substituted benzimidazole derivative, which suppresses the final step in gastric acid production by forming a covalent bond to two sites of the H+, K+ - ATPase enzyme system at the secretory surface of the gastric parietal cell. This leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus. The binding to the H+/K+ - ATPase results in duration of antisecretory effect that persists longer than 24 hours. Pantoprazole (P-lock) is quantitatively absorbed and bioavailability does not change upon multiple dosing. Pantoprazole (P-lock) is extensively metabolized in the liver. Almost 80% of an oral dose is excreted as metabolites in urine; the remainder is found in feces and originates from biliary secretion.

 

Indications and Usage

Pantoprazole (P-lock) is indicated where suppression of acid secretion is of therapeutic benefit. Pantoprazole (P-lock) is registered for the following indications: -

1. Peptic ulcer diseases (PUD)

2. Gastro esophageal reflux diseases (GERD)

3. Treatment of ulcer resistant to H2 receptor antagonists (H2RAs)

4. Treatment of ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs)

5. Gastrointestinal (GI) bleeding from stress or acid peptic diseases

6. Eradication of Helicobacter pylori (in combination with antibiotics)

7. Zollinger-Ellison syndrome

8. Prophylaxis for acid aspiration syndrome during induction of anaesthesia

 

Dosage and Administration

Delayed release tablet

The usual recommended adult oral dose is 40 mg given once daily, before breakfast. The duration of therapy is ranging from 2-8 weeks. Duodenal Ulcers: P-lock 40 mg tablet, once daily for 2 to 4 weeks. Duodenal ulcer generally heals within 2 weeks. Gastric ulcers: P-lock 40 mg tablet, once daily for 4 to 8 weeks. Gastric ulcer generally heals within 4 weeks. Reflux esophagitis: P-lock 40 mg tablet, once daily for 4 to 8 weeks. Reflux esophagitis generally heals within 4 weeks of treatment. In resistant ulcers: P-lock 40 mg tablet, once daily for 8 weeks. Ulcers induced by NSAIDs: P-lock 40 mg tablet once daily, in patients receiving continuous treatment with NSAIDs. GI bleeding from stress or acid peptic diseases: Usual adult oral dosage, if required the dosage may be increased. Eradication of Helicobacter pylori: Triple therapy of P-lock 40 mg twice daily in combination with appropriate antibiotic for one week achieved eradication rates of 90 to100%. Zollinger-Ellison syndrome: 4 P-lock 40 mg tablets per day. Once control of acid secretion has been achieved, the dose should be gradually reduced to the lowest effective dose that maintains acid control. Prophylaxis for acid aspiration syndrome during induction of anaesthesia: 1 or 2 P-lock 40 mg tablet should be given the evening before surgery and repeated again the morning of surgery.

 

Maintenance therapy

Maintenance treatment should involve the lowest dose of the drug. Both 20 and 40 mg doses of Pantoprazole (P-lock) are safe and effective in maintaining patients with healed reflux esophagitis and PUD in remission.

 

Contraindication

P-lock delayed release tablets are contraindicated in patients with known hypersensitivity to any of the formulation.

 

Precautions

Patients should be cautioned that P-lock delayed release tablets should not be split, chewed or crushed.

 

Side effects

Potentially life-threatening effects: None has been reported with respect to Pantoprazole.

Severe or irreversible adverse effects: No serious adverse reactions have been described to date.

Symptomatic adverse effects: Headache (1.3%) and diarrhoea (1.5%) are the two commonest reported adverse events. It doesn't influence renal, cardiovascular, respiratory, endocrine, cognitive or motor functions and no consistent change have been found in any biochemical or haematological parameters. Peripheral edema has occasionally been reported in female patients. Other side effects may include abdominal pain, dizziness, nausea, epigastric discomfort, flatulence, skin rash, pruritus etc. 

 

Pregnancy & Lactation 

Pregnant women: USFDA pregnancy category B. Studies using animals have not found any risk to the fetus.

Lactating mother: There are no data on the excretion of Pantoprazole into the breast milk.

Neonates & Children

No data are available on administration of Pantoprazole.

 

Elder patient

No problems with Pantoprazole have been encountered in clinical use in this patient group.

 

Concurrent disease

No dosage adjustment of Pantoprazole is required in patients with mild, moderate or severe renal insufficiency or in elderly patients. No dosage adjustment is necessary in patients undergoing haemodialysis. No dosage adjustment is needed in patients with mild or moderate hepatic impairment. In hepatic cirrhosis, it is recommended that the dosing is reduced to every other day.

 

Drug Interactions

Pantoprazole is metabolized through the cytochrome P-450 system, and subsequently undergoes Phase II conjugation. Based on studies evaluating possible interactions of Pantoprazole with other drugs metabolized by the cytochoreme P-450 system, no dosage adjustment is needed with concomitant use of the following drugs; theophylline, antipyrine, caffeine, carbamazepine, diazepam, diclofenac, digoxin, ethanol, glyburide, an oral contraceptive (Levonorgestrel/ethinyl estradiol), metoprolol, nifedipine, phenytion, or warfarin. There was also no interaction with concomitantly administered antacids.

 

Overdosage

There are no known symptoms of overdosage in humans. Since Pantoprazole is highly protein bound, it is not readily dialyzable. Apart from symptomatic and supportive management, no specific therapy is recommended.

 

Commercial Pack

P-lock 20 tablet: Each box contains 6 Alu-Alu blister strips of 10 tablets.

P-lock 40 tablet: Each box contains 3 Alu-Alu blister strips of 10 tablets.

Wednesday, 09 March 2016 19:02

Onecal-M

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Onecal-M

Calcium, Vitamin-D3 & Minerals

 

Composition

Onecal-M Tablet: Each film coated tablet contains Calcium BP 500 mg, Vitamin-D3 BP 200 IU, Zinc Oxide BP 9.71 mg, Cupric Oxide BP 4.94 mg, Magnesium Oxide BP 66.32 mg, Manganese Sulphate BP 4.94 mg, Boron Citrate BP 4.26 mg.

 

Description

Calcium is an essential element and plays vital roles in the body. It helps body's framework stronger by building bone. Clinical evidence suggests that calcium is useful for prevention and treatment of osteoporosis and associated fractures. Vitamin-D is also essential for healthy bones as it aids in calcium absorption from the GI tract. In addition to this it stimulates bone formation. Controlled clinical studies shows that calcium and vitamin-D has synergistic effects on bone growth as well as in osteoporosis and fracture prevention.

 

Indication

• Treatment of osteoporosis, rickets, osteomalacia, tetany and hypoparathyroidism

• In pregnancy & lactation due to increase demand

• In kidney disease and pancreatitis

• During therapy with antiseizure medications

• The prevention and treatment of calcium deficiency/vitamin D deficiency especially in the housebound and institutionalized elderly subjects.

 

Dosage and Administration

Adults and Elderly and children above 12 years of age: 2 tablets per day, preferably one tablet each morning and evening.Children: Not recommended for children under 12 years.

 

Side Effect

The use of calcium supplements has, rarely, given rise to mild gastro-intestinal disturbances, such as constipation, flatulence, nausea, gastric pain, diarrhoea. Following administration of vitamin D supplements occasional skin rash has been reported. Hypercalciuria, and in rare cases hypercalcaemia have been seen with long term treatment at high dosages.

 

Contraindication

Absolute contra-indications are hypercalcaemia resulting for example from myeloma, bone metastases or other malignant bone disease, sarcoidosis; primary hyperparathyroidism and vitamin D overdosage. Severe renal failure. Hypersensitivity to any of the tablet ingredients. Relative contra-indications are osteoporosis due to prolonged immobilisation, renal stones, severe hypercalciuria.

 

Overdose

The most serious consequence of acute or chronic overdose is hypercalcaemia due to vitamin D toxicity. Symptoms include nausea, vomiting, polyuria, and constipation. Chronic overdoses can lead to vascular and organ calcification as a result of hypercalcaemia. Treatment should consist of stopping all intake of calcium and vitamin D and rehydration.

 

Precaution

Patients with mild to moderate renal failure or mild hypercalciuria should be supervised carefully. Periodic checks of plasma calcium levels and urinary calcium excretion should be made in patients with mild to moderate renal failure or mild hypercalciuria. Urinary calcium excretion should also be measured. In patients with a history of renal stones urinary calcium excretion should be measured to exclude hypercalciuria. With long-term treatment it is advisable to monitor serum and urinary calcium levels and kidney function, and reduce or stop treatment temporarily if urinary calcium exceeds 7.5mmol/24 hours. Allowances should be made for calcium and vitamin D supplements from other sources.

 

Use in Pregnancy & Lactation

During pregnancy and lactation treatment should always be under the direction of a physician. During pregnancy and lactation, requirements for calcium and vitamin D are increased but in deciding on the required supplementation allowances should be made for availability of these agents from other sources. If calcium iron supplements are both required to be administered to the patient, they should be taken at different times. Overdoses of vitamin D have shown teratogenic effects in pregnant animals. In humans, long term hypercalcaemia can lead to physical and mental retardation, aortic stenosis and retinopathy in a new born child. Vitamin D and its metabolites pass into the breast milk. children.

 

Commercial Pack

Onecal-M Tablet: Each box containing 3x10’s tablets of Alu-PVC blister.

Wednesday, 09 March 2016 18:59

Onecal-D

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Onecal-D

Calcium 500 mg & Vitamin D3 200 IU

 

Composition

Onecal-D Tablet: Each film coated tablet contains Calcium Carbonate BP 1250 mg equivalent to elemental Calcium 500 mg, Vitamin-D3 BP 200 IU as Cholecalciferol.

 

Description

Calcium is needed for the formation of strong bones and healthy teeth and is involved in helping the blood to clot. It is also required to transmit nerve signals and help muscles work. Inadequate Calcium intake results in reduced bone mass and osteoporosis. Vitamin D3 is needed for Calcium to be absorbed from the gut and deficiency can lead to low Calcium levels and subsequent weakening of bones. Calcium and vitamin- D3 has synergistic effects on bone growth as well as in osteoporosis and in fracture prevention.

 

Indication

Calcium and Vitamin- D3 is used for the treatment of osteoporosis, osteomalacia, rickets, tetany, disorders of osteogenesis and tooth formation (addition to specific treatment) and parathyroid disease.

Also used in raised Calcium requirement for children and adolescents at times of rapid growth and during pregnancy and lactation. It is also used as routine supplement and phosphate binder in chronic renal failure.

 

Dosage and Administration

Adults and Elderly : The usual doses are two tablets daily at morning and evening. Higher doses should not be used unless recommended by the physician. Tablet must be swallowed. 

 

Side Effect

Orally administered Calcium Carbonate may be irritating to the GI tract. It may also cause constipation. Hypercalcaemia is rarely produced by administration of Calcium alone, but may occur when large doses are given to patients with chronic renal failure. Also there may be occasional allergic reactions, irregular heartbeats, nausea, vomiting, decreased appetite, dry mouth and drowsiness. Following the administration of Vitamin D3 supplements occasional skin rash has been reported.

 

Contraindication

It is contraindicated in case of hypercalcaemia, hyperthyroidism, renal calculi & nephrolithiasis, Zoliinger-Elison syndrome and in concomitant digoxin therapy.

 

Overdose

Symptoms of overdose may include nausea and vomiting, severe drowsiness, dry mouth, loss of appetite, metallic taste, stomach cramps, unconsciousness, diarrhea, weakness, headache, constipation, dizziness or irritability.

 

Precaution

Patients with mild to moderate renal failure or mild hypercalciuria should be supervised carefully. Periodic checks of plasma calcium levels and urinary calcium excretion should be made in patients with mild to moderate renal failure or mild hypercalciuria. Urinary calcium excretion should also be measured. In patients with a history of renal stones urinary calcium excretion should be measured to exclude hypercalciuria. With long-term treatment it is advisable to monitor serum and urinary calcium levels and kidney function, and reduce or stop treatment temporarily if urinary calcium exceeds 7.5mmol/24 hours. Allowances should be made for calcium and vitamin D supplements from other sources.

 

Use in Pregnancy & Lactation

During pregnancy and lactation treatment should always be under the direction of a physician. During pregnancy and lactation, requirements for calcium and vitamin D are increased but in deciding on the required supplementation allowances should be made for availability of these agents from other sources. If calcium iron supplements are both required to be administered to the patient, they should be taken at different times. Overdoses of vitamin D have shown teratogenic effects in pregnant animals. In humans, long term hypercalcaemia can lead to physical and mental retardation, aortic stenosis and retinopathy in a new born child. Vitamin D and its metabolites pass into the breast milk. children.

 

Commercial Pack

Onecal-D Tablet: Each box containing 3x10’s tablets of Alu-PVC blister.

Wednesday, 09 March 2016 18:55

Onecal

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Onecal

Calcium 500 mg

 

Presentation

Onecal Tablet: Each film coated tablet contains Calcium Carbonate BP 1250 mg equivalent to Calcium 500 mg.

 

Indications

Indicated in raised calcium requirement e.g. during pregnancy and lactation, and in children and adolescents at time of rapid growth, inadequate intake of calcium in the diet due to malnutrition, prevention and treatment of osteoporosis, disorders of osteogenesis and tooth formation, latent tetany.

 

Dosage and Administration

Adult: One Onecal 500 tablet or as directed by the physician. For the prevention of osteoporosis, 1-3 Calpro tablet is recommended generally as a dietary supplement . Doses for children is half of those for adults. A large dose should not be taken without physician's advice.

Adolescent: One to two Onecal tablet daily.

Children: One Onecal tablet daily.

 

Contraindications

Hypersensitivity to any component of this preparation, Hypercalcemia, Hyper-parathyroidism, Zolinger-Ellison Syndrome, Concomitant Digoxin therapy, Severe hypercalciuria, Severe renal insufficiency, Nephrolithiasis.

 

Side-effects

In rare cases, flatulence, diarrhoea or constipation.

 

Use in pregnancy & lactation

Pregnant women : Calcium containing drugs are used widely in pregnancy by way of calcium supplement or antacid therapy. No relationship between malformation in general and calcium exposure has been noted.

Lactating mother : There is no contraindication to the use of calcium carbonate in lactating mother.

 

Drug interactions

Oral calcium can reduce internal absorption of tetracycline and fluoride preparations and an interval of at least 3 hours should therefore be allowed between ingestion of these medications. Vitamin D increases internal absorption of calcium. The intestinal uptake of calcium may be reduced by concomitant ingestion of certain foods (e.g. spinach, milk and milk products).

 

Commercial Pack

Onecal Tablet: Each box containing 6x10’s tablets of Alu-PVC blister.

Wednesday, 09 March 2016 18:52

Omelock

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Omelock

Omeprazole

 

Presentation

Omelock 20 capsule : Each capsule contains Omeprazole BP 20 mg as enteric coated 8.5% pellets.

Omelock 40 capsule : Each capsule contains Omeprazole BP 40 mg as enteric coated 8.5% pellets.

 

Description

Omeprazole is a substituted benzimidazole that suppresses gastric acid secretion by specific inhibition of the gastric acid proton pump (H+/K+ ATPase enzyme) at the secretory surface of the gastric parietal cell. It blocks the final step of acid secretion. After oral administration, the onset of the antisecretory effect of Omeprazole occurs within one hour, with the maximum effect occurring within two hours and the duration of inhibition lasts up to 72 hours. The antisecretory effect lasts far longer than would be expected from the very short (less than one hour) plasma half-life, apparently due to prolonged binding to the parietal H+/K+ ATPase enzyme. Following absorption, Omeprazole is almost completely metabolized and rapidly eliminated mostly through urine.

 

Indications and Uses

Omelock (Omeprazole) is indicated for the treatment of-

Heartburn, Any symptoms of GERD, Erosive esophagitis (both curative and maintenance therapy), Duodenal ulcer, Gastric ulcer, Reduction of risk of upper GI bleeding in critically ill patients.

 

 

Dosage and Administration

Omelock (Omeprazole) should be taken before meal. No dosage adjustment is necessary for patients with renal impairment, hepatic dysfunction or for the elderly.

Duodenal Ulcer: The recommended adult oral dose is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

Gastric Ulcer: The recommended adult oral dose is 40 mg once a day for 4-8 weeks.

Gastroesophageal Reflux Disease (GERD): The recommended adult oral dose is 20 mg daily for up to 4 weeks.

Erosive esophagitis: The recommended adult oral dose is 20 mg daily for 4 to 8 weeks.

Zollinger-Ellison syndrome: The recommended adult oral starting dose is 60 mg once a day. Dosage should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg t.i.d. have been administered. Daily dosages of greater than 80 mg should be administered in divided doses.

 

Side Effects

Omeprazole is well tolerated and adverse reactions have generally been mild and reversible. Side effects may include headache, diarrhoea, constipation, abdominal pain, nausea/vomiting and flatulence, dizziness, paraesthesia, somnolence, insomnia and vertigo, increased liver enzymes, rash, dermatitis and/or pruritis, urticaria, Malaise. Others include hypersensitivity reactions e.g. angioedema, fever, bronchospasm, interstitial nephritis and anaphylactic shock.

 

Precautions

Symptomatic response to therapy with Omeprazole does not preclude the presence of gastric malignancy. Immediate Release Omeprazole formulations contain sodium bicarbonate which should be taken into consideration for patients on a Sodium-restricted diet.

 

Use in Pregnancy and Lactation

Pregnancy: There are no adequate and well-controlled studies on the use of Omeprazole in pregnant women. Therapeutic doses during pregnancy are unlikely to pose a substantial teratogenic risk. Omeprazole should be used during pregnancy only if the potential benefit to pregnant women justifies the potential risk to the fetus.

 

Lactation: Omeprazole is excreted in human milk. Thus, a decision should be taken to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.   

 

Contraindications

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

 

Drug interactions

Omeprazole can prolong the elimination of Diazepam, Warfarin, Phenytoin and other vitamin K antagonists. No interaction with Theophylline or Propranolol was found. There have been clinical reports of interaction with other drugs metabolized via the cytochrome P-450 system e.g. Cyclosporine, Disulfiram, Benzodiazepines. Patients should be monitored to determine if it is necessary to adjust the dosage of these drugs when taken concomitantly with Omeprazole.

 

Overdose

Symptoms were transient, and no serious clinical outcome has been reported with Omeprazole overdose. No specific antidote for Omeprazole overdose is known. Omeprazole is extensively bound with protein and is, therefore, not readily dialyzable. In the event of overdose, treatment should be symptomatic and supportive.

 

Pharmaceutical Precautions

Patients should be cautioned that the Omeprazole capsule should not be chewed or crushed and should be swallowed whole. Omeprazole should be stored in a cool and dry place, away from light. Keep out of the reach of children.

 

Commercial Pack

Omelock 20 capsule : Each box contains 6 alu-alu blister strips of 10 capsules.

Omelock 40 capsule : Each box contains 3 alu-alu blister strips of 10 capsules.

Wednesday, 09 March 2016 18:46

Ocimax

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Ocimax

Ciprofloxacin

 

Presentation

Ocimax 500 Tablet: Each film coated tablet contains Ciprofloxacin Hydrochloride BP equivalent to Ciprofloxacin 500 mg.

Ocimax Granules for suspension 60 ml: Each 5 ml contains Ciprofloxacin BP 250 mg.

 

Description

Ciprofloxacin is a synthetic 4-quinolone derivative with bactericidal activity against a wide range of gram-positive and gram-negative organism. It is active against most gram-negative aerobic bacteria including Enterobacteriaceae and Pseudomonas aeruginosa. Ciprofloxacin is also active against gram-positive aerobic bacteria including penicillinase producing, non-penicillinase producing and methicillin resistant Staphylococci. However many strains of Streptococci are relatively resistant to the drug. The bactericidal activity of Ciprofloxacin results from interference with the enzyme DNA gyrase needed for the synthesis of bacterial DNA. The mode of action of Ciprofloxacin is different from other antibiotics like penicillins, cephalosporins, aminoglycosides, tetracyclines and for this reason it is observed that organisms resistant to these antibiotics are susceptible to Ciprofloxacin. Ciprofloxacin is well absorbed from the GIT after oral administration and it is widely distributed into the body tissues and fluid. The half-life of Ciprofloxacin is 3.5 - 4.5 hours. About 30-50% of an oral dose of Ciprofloxacin is excreted in the urine within 24 hours as unchanged drug and active metabolites.

 

Indications

Ciprofloxacin is indicated for the treatment of the following infections caused by sensitive bacteria:

Severe systemic infections: e.g; septicemia, bacteremia, peritonitis, infections in immunosuppressed patients with haematological or solid tumors and in patients in intensive care unit with specific problems such as infected burns.

Respiratory tract infections: Lobar and broncho pneumonia, acute and chronic bronchitis and empyema.

Urinary tract infections: Uncomplicated and complicated urethritis, cystitis, pyelonephritis, prostatitis and epididymitis.

Skin and soft tissue infections: Infected ulcers, wound infections, abscesses, cellulitis, otitis externa, erysipelas and infected burns.

Gastrointestinal infections: Enteric fever, infective diarrhea.

Infections of the biliary tract: Cholangitis, cholecystitis, empyema of the gall bladder.

Intra-abdominal infections: Peritonitis, intra abdominal abscesses.

Bone and joint infections: Osteomyelitis, septic arthritis.

Pelvic infections: Salpingitis, endometritis, pelvic inflammatory diseases.

Eye, ear, nose and throat infections: Otitis media, sinusitis, mastoiditis, tonsillitis.

Gonorrhoea: Urethral, rectal and pharyngeal gonorrhoea caused by beta-lactamase producing organism or organisms moderately sensitive to penicillin.

 

Dosage and Administration

Adult :

* use in conjunction with metronidazole

 

Children and adolescents:

RTI & GI infections: Neonate-15mg/kg twice daily, Child (1 month -18 years)-20mg/kg (max 750 mg) twice daily; UTI: Neonate-10 mg/kg twice daily, Child (1 month -18 years)-10mg/kg (max 750 mg) twice daily; Pseudomonal lower respiratory tract infection in cystic fibrosis: Child (1 month -18 years) - 20mg/kg (max 750 mg) twice daily; Anthrax (treatment & post exposure prophylaxis): Child (1 month -18 years) - 20mg/kg (max 750 mg) twice daily.

Use in Pregnancy and Lactation

Reproduction studies performed in rats and rabbits using parenteral and oral administration did not reveal any evidence of teratogenicity, impairment of fertility or impairment of pre or postnatal development. However, as with other quinolones, Ciprofloxacin has been shown to cause arthropathy in immature animals and therefore, its use during pregnancy is not recommended. Studies in rats have indicated that Ciprofloxacin is secreted in milk, administration to nursing mothers is thus not recommended.

 

Side effects

Ciprofloxacin is generally well tolerated. Frequent adverse reactions are- Gastrointestinal disturbance: e.g. nausea, diarrhea, vomiting, dyspepsia, abdominal pain. Disturbance of the CNS: e.g. dizziness, headache, tiredness, confusion, convulsions. Hypersensitivity reactions: e.g. skin rashes, pruritus, and possible systemic reactions. Other possible side effects are - joint pain, light sensitivity, transient increase in liver enzyme (especially in patients with history of liver damage), serum bilirubin, urea or serum creatinine. Arthralgia and myalgia may also occur.

 

Contraindications

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

 

Precautions

Ciprofloxacin should be used with caution in patients with a history of convulsive disorders. Crystalluria related to the use of Ciprofloxacin has been observed only rarely. Patients receiving Ciprofloxacin should be well hydrated to avoid excessive alkalinity of the urine.

 

Drug interactions

Concurrent administration of Ciprofloxacin with theophylline may lead to elevated plasma concentrations of theophylline. Plasma level of theophylline should be monitored and dosage adjustments made as appropriate. Antacid containing magnesium hydroxide or aluminium hydroxide may interfere with the absorption of Ciprofloxacin & concurrent administration of these agents with Ciprofloxacin should be avoided. Probenecid interferes with renal tubular secretion of Ciprofloxacin and produces an increase in the level of Ciprofloxacin in the serum. As with other broad spectrum antibiotics prolonged use of Ciprofloxacin may result in over growth of non-susceptible organisms. Repeated evaluation of patient's conditions and microbial susceptibility testing is essential. If superinfections occur during therapy, appropriate measure should be taken.

 

Information for patients

Ocimax should be swallowed whole with an adequate amount of liquid, it may be taken with or without meals. The preferred time of dosing is two hours after a meal and patients should not take antacid within two hours of dosing.

 

Commercial pack

Ocimax 500 Tablet: Each box containing 3x10’s tablets of Alu-PVC blister.

Ocimax Granules for suspension 60 ml: Each glass bottle contains Granules for preparing 60 ml  suspension.

Wednesday, 09 March 2016 18:21

Kelorac 10

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Kelorac 10

Ketorolac

 

Presentation

Kelorac 10 tablet: Each film coated tablet contains Ketorolac Tromethamine USP 10 mg.

 

Description

Ketorolac Tromethamine is a drug of pyrrolo-pyrrole group of nonsteroidal antiinflammatory drug (NSAID). Chemically it is known as ±5 benzoyle-2,3-dihydro-1H-pyrroligine-1-carboxylic acid, compound with 2 amino-2-(hydroxymethyl)-1,3-propanediol. Ketorolac Tromethamine inhibits synthesis of prostaglandins and may be considered as a peripherally acting analgesic. The biological activity of Ketorolac Tromethamine is associated with the S-form. Pharmacokinetic property of Ketorolac Tromethamine is linear. It is highly protein bound and is largely metabolized in liver. The products of metabolism and some unchanged drugs are excreted in the urine.

 

Indications and Uses

Ketorolac Tromethamine is indicated for the short-term (5 days) management of moderate to severe  acute pain that requires analgesia at the opiod level (usually in a postoperative setting).

 

Dosage and Administration

By mouth: 10 mg every 4-6 hours (elderly, every 6-8 hours) or 40mg daily; maximum duration of treatment is 7 days.

 

Side effects

It is generally well tolerated. However, side effects like dry mouth, excessive thirst, psychotic reactions, convulsion, myalgia, hyponatremia, hyperkalemia, raised blood urea and creatinine, renal failure, hypertension, bradycardia, chest pain, purpura, post operative haemorrhage, haematoma, liver function change etc may occur in some cases.

 

Contraindications

Ketorolac Tromethamine is contraindicated in patients with known hypersensitivity to NSAIDs and any of the components of Ketorolac Tromethamine. Moreover, the patient with the history of asthma, nasal polyp, angioedema, peptic ulcer and bleeding, bleeding disorder are contraindicated for this drug.

 

Precautions

Precaution should be taken in the following conditions

- Elderly

- Allergic disorder

- Renal, cardiac & hepatic impairment

- Porphyria

- Patient with low body weight (<50kg): reduce dose.

 

Use in pregnancy & lactation

Ketorolac Tromethamine is contraindicated in pregnancy and lactation.

 

Use in children

Not recommended for children below 16 years of age.

 

Drug Interaction

Warfarin, digoxin, heparin and salicylate should be used carefully with Ketorolac Tromethamine. 

 

Over dosage

Overdosage of Ketorolac Tromethamine may cause abdominal pain, peptic ulcers which healed after discontinuation of doses. Metabolic acidosis has been reported following intentional overdosage.

 

Commercial Pack :

Kelorac 10  tablet : Each box contains 3 Alu-Alu blister strips of 10 tablets.

Wednesday, 09 March 2016 18:05

Airway

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Airway

Montelukast

 

Presentation

Airway 5 Tablet: Each film coated tablet contains Montelukast Sodium BP equivalent to Montelukast 5 mg.

Airway 10 Tablet: Each film coated tablet contains Montelukast Sodium BP equivalent to Montelukast 10 mg.

 

Description

Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT1 receptor. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma ( such as, airway edema, smooth muscle contraction and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma).

 

Indications and Uses

Montelukast is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients.

 

Dosage and Administration

Adults  (15 years of age or over): 10 mg daily to be taken in the evening.

Children (6-14 years of age): 5 mg daily to be taken in the evening.

The safety and efficacy of Montelukast was demonstrated in clinical trials where it was administered in the evening without regard to the time of food ingestion.

 

Side effects

Generally, Montelukast is well-tolerated. Side effects include dizziness, headache, diarrhea, restlessness, abdominal pain, cough, fever, asthenia, rash and upper respiratory tract infection.

 

Contraindication

Montelukast is contraindicated to patients with hypersensitivity to any component of this product.

 

Precautions

Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks (in case of status asthmaticus).

Patients with known aspirin sensitivity should continue avoidance of aspirin or other NSAID, while taking Montelukast.

In rare cases, patients on therapy with Montelukast may present with systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with churg-strauss syndrome, a condition which is often treated with systemic corticosteroid therapy. Physician should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal association between Montelukast and these underlying conditions has not been established.

 

Use in pregnancy and lactation

Pregnancy: There are no adequate and well-controlled studies of Montelukast in pregnant women. Because animal reproductive studies are not always predictive of human response, so Montelukast should be used during pregnancy only if clearly needed.

Lactation: It is not known if Montelukast is excreted in human milk. Because many drugs are excreted in human milk, so caution should be exercised when Montelukast is given to a nursing mother.

 

Drug interaction

Montelukast has been administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma with no appropriate increase in adverse reactions.

Cytochrome P-450 inducers: Although Phenobarbital induces hepatic metabolism, no dosage adjustment for Montelukast is recommended. It is reasonable to employ appropriate clinical monitoring when potent cytochrome P-450 enzyme inducers, such as Phenobarbital or Rifampin, are co-administered with Montelukast.

 

Overdosage

There were no adverse experiences reported in the majority of overdosage reports. The most frequent adverse experiences observed were thirst, mydriasis, hyperkinesia, and abdominal pain. 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.

 

Commercial Pack

Airway  5 Tablet: Each box contains 2 Alu-Alu blister strip of 10 tablets.

Airway 10 Tablet: Each box contains 2 Alu-Alu blister strip of 10 tablets.

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