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One Pharma Ltd | Leading Pharmaceuticals in Bangladesh - By Trade Name
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Sunday, 16 October 2016 04:07

Ozink-B

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Ozink-B

(Zinc & Vitamin B Complex Syrup)

 

Presentation

Ozink-B syrup: Each 5 ml syrup contains Zinc Sulfate Monohydrate USP 27.45 mg equivalent to Elemental Zinc 10 mg, Thiamine Hydrochloride (B1) BP 5 mg, Riboflavin 5-Phosphate Sodium BP 2.74 mg equivalent to Riboflavin (B2) 2 mg, Pyridoxine Hydrochloride (B6) BP 2 mg, Nicotinamide (B3) BP 20 mg.

 

Description

Ozink-B is a special preparation of B-Vitamins and Zinc.

 

Indications

Ozink-B is indicated for the treatment and prevention of B-vitamins and Zinc deficiencies. B-vitamins are needed to release energy from food. They play an important role in ensuring healthy brain and nerve function, formation of healthy red blood cells (RBC) in children & adults. They are specially required for healthy growth and development of children. Zinc is necessary to maintain a healthy immune system. It ensures normal growth & sexual development of children. It is further necessary for the growth and maintenance of muscles.

 

Dosage & Administration

Ozink-B syrup

Adults: 10 ml (1 measuring cup) 2 to 3 times daily or as recommended by the physician.

Children: 10 ml (1 measuring cup) 1 to 3 times daily or as recommended by the physician.

Infants: 5 ml (1/2 measuring cup) 1 to 2 times daily or as recommended by the physician.

 

Side Effect

Ozink-B is generally well tolerated.

 

Contraindication

Ozink-B is contraindicated in patients with a known hypersensitivity to any of the ingredients of this product.

 

Use in Pregnancy & Lactation

Recommended.

 

Overdose

In case of overdosage, initially epigastric pain, diarrhoea and vomiting can occur. Should seek emergency medical attention immediately. Initially an emetic should be given and then gastric lavage and general supportive measures should be employed.

 

Storage

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

 

Commercial Pack

Ozink-B syrup 100 ml: Each amber PET bottle contains 100 ml syrup with a measuring cup.

Sunday, 16 October 2016 03:56

Onepro

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Onepro

(Esomeprazole)

Presentation

Onepro 20 tablet: Each delayed release tablet contains Esomeprazole Magnesium Trihydrate BP equivalent to Esomeprazole 20 mg.

Onepro 40 tablet: Each delayed release tablet contains Esomeprazole Magnesium Trihydrate BP equivalent to Esomeprazole 40 mg.

 

Description

Esomeprazole (Onepro) is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+ATPase in the gastric parietal cell. By acting specifically on the proton pump, Onepro blocks the final step in acid production, thus reducing gastric acidity.

 

 

Indications and Usage

Treatment of Gastroesophageal Reflux Disease (GERD)

Healing of Erosive Esophagitis

Maintenance of Healing of Erosive Esophagitis

Symptomatic Gastroesophageal Reflux Disease

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Zollinger-Ellison Syndrome

Acid Related Dyspepsia

Duodenal and Gastric Ulcer

 

Dosage and Administration

Tablet: The recommended adult dosages are outlined in the table below. Onepro delayed release tablet/capsule should be swallowed whole and taken at least one hour before eating.

The majority of patients are healed within 4 to 8 weeks. For patients who do not heal after 4-8 weeks, an additional 4-8 weeks of treatment may be considered.

**If symptoms do not resolve completely after 4 weeks, an additional 4 weeks of treatment may be considered.

 

Use in Pregnancy and Lactation

In Pregnancy: Pregnancy Category B. This drug should be used during pregnancy only if clearly needed.

 

In Lactation: The excretion of Esomeprazole in milk has not been studied. As Esomeprazole 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.

 

Side-effects

In general, Esomeprazole was well tolerated in both short- and long-term clinical trials. The most frequently occurring adverse events (≥1%) are headache and diarrhea. Nausea, flatulence, abdominal pain, constipation and dry mouth occurred at similar rates among patients taking Esomeprazole.

 

Contraindications

Esomeprazole is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted Benzimidazoles.

 

Precautions

Symptomatic response to therapy with Esomeprazole does not preclude the presence of gastric malignancy. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole, of which Esomeprazole is an enantiomer.

 

Drug Interactions

Drug interaction studies have shown that Esomeprazole does not have any clinically significant interactions with Phenytoin, Warfarin, Quinidine, Clarithromycin or Amoxicillin.  Esomeprazole inhibits gastric acid secretion. Therefore, Esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg, Ketoconazole, Iron salts and Digoxin). Coadministration of oral contraceptives, Diazepam, Phenytoin or Quinidine did not seem to change the pharmacokinetic profile of Esomeprazole.

 

Commercial Pack

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

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

Sunday, 16 October 2016 03:21

Onefix

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CapsulOnefix

(Cefixime)

Presentation

Onefix 200 Capsule: Each capsule contains Cefixime Trihydrate USP equivalent to Cefixime 200 mg.

Onefix 400 Capsule: Each capsule contains Cefixime Trihydrate USP equivalent to Cefixime 400 mg.

Onefix 30 ml Powder for Suspension: After reconstitution according to direction, each 5 ml suspension contains Cefixime Trihydrate USP equivalent to Cefixime 100 mg.

Onefix 50 ml Powder for Suspension: After reconstitution according to direction, each 5 ml suspension contains Cefixime Trihydrate USP equivalent to Cefixime 100 mg.

 



Description:

Cefixime is a semi-synthetic, broad spectrum cephalosporin antibiotic of third generation for oral administration. It is a bactericidal antibiotic, kills bacteria by interfering in the synthesis of the bacterial cell wall. Cefixime is highly stable in the presence of beta-lactamase enzymes. Cefixime has marked in-vitro bactericidal activity against a wide variety of Gram-positive and Gram-negative organisms including beta lactamase producers.

Clinical efficacy of Cefixime has been demonstrated in infections caused by commonly occurring pathogens including Gram-positive organism Streptococcus pneumoniae, Streptococcus pyogenes, Gram-negative organism Escherichia coli, Proteus mirabilis, Klebsiella spp., Haemophilus influenzae (beta-lactamase positive and negative), Moraxella catarrhalis (beta-lactamase positive and negative), Salmonella typhi and Enterobacter species.

 

Indications and Uses:

Onefix is indicated in the following infectious diseases -

Respiratory Tract Infections:

Pneumonia

Sinusitis

Pharyngitis and Tonsillitis

Acute Bronchitis and Acute Exacerbations of Chronic Bronchitis (AECB)

Otitis Media

Typhoid Fever

Urinary Tract Infection

Uncomplicated gonorrhea (cervical/urethral)

 

Dosage and Administration:

The usual treatment of Onefix is 7 days. This may be continued for up to 14 days according to the severity of infection.

Side-effects

Cefixime is generally well tolerated. The majority of adverse reactions observed in clinical trials are mild and self limiting in nature.

Gastro-intestinal disturbance: Diarrhoea (if severe diarrhoea occurs, Cefixime should be discontinued), changes in the color of stool, nausea, abdominal pain, dyspepsia, vomiting, flatulence have been reported.

CNS disturbances: Headache, dizziness.

Others: Hypersensitivity reactions which usually subsided upon discontinuation of therapy; infrequent and reversible hematological changes; elevation of serum amylase.

 

Precautions

Cefixime should be prescribed with caution in individuals with a history of gastrointestinal diseases, particularly colitis.  Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min)

 

Use in Pregnancy and Lactation

Pregnancy: Pregnancy category B. There are 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.

Lactation: It is not known whether Cefixime is excreted in human milk. Consideration should be given to discontinuing nursing temporarily during treatment with this drug.

 

Use in Elderly

No special precautions are necessary. No dosage adjustment is required for elderly.

 

Contraindication

Patients with known hypersensitivity to Cefixime or cephalosporin group of drugs.

 

Drug Interactions

Carbamazepine: Elevated carbamazepine levels have been reported in postmarketing experience when Cefixime is administered concomitantly. Drug monitoring may be of assistance in detecting alterations in carbamazepine plasma concentrations.

Warfarin and Anticoagulants: Increased prothrombin time, with or without clinical bleeding, has been reported when cefixime is administered concomitantly.

 

Direction for Reconstitution of Suspension

uTo prepare 50 ml suspension, 30 ml boiled and cooled water is required.

uTo prepare 30 ml suspension, 20 ml boiled and cooled water is required.

 

Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half of the total amount of water and shake well. Add remainder of water, and then shake again.

Note:  Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place, preferably in refrigerator and unused portion should be discarded after 14 days.

 

Overdosage

Gastric lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

 

Commercial Pack

Onefix 200 Capsule: Box containing 2 Alu-Alu blister strips of 6 capsules.

Onefix 400 Capsule: Box containing 2 Alu-Alu blister strip of 4 capsules.

Onefix 30 ml Powder for Suspension: Bottle containing powder for the preparation of 30 ml suspension.

Onefix 50 ml Powder for Suspension: Bottle containing powder for the preparation of 50 ml suspension.

 

Sunday, 16 October 2016 03:17

Onecof

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Onecof

Ambroxol

 (Presentation)


Onecof Syrup: Each 5 ml syrup contains Ambroxol hydrochloride BP 15 mg.

 

Description

Ambroxol is the active metabolite of Bromhexine and it has a greater bronchosecretolytic effect than Bromhexine. Ambroxol stimulates the serous cells of the glands of the mucous membrane of bronchi, increasing the content of mucus secretion. The mucolytic effect is associated with depolymerization and splitting of mucoproteins and mucopolysaccharide fibres, which leads to reduction in the viscosity of mucus. Expectoration of mucus is facilitated and breathing is eased considerably. Ambroxol stimulates production of phospholipids of surfactant by alveolar cells. Ambroxol has anti-inflammatory properties. In patients with COPD, it improves airway patency. Beside these, Ambroxol also exhibits anti-oxidant activity. Long-term use is possible because of the good tolerability of the preparation.

 

Indications

Acute and chronic diseases of respiratory tracts associated with viscid mucus

including acute and chronic bronchitis

Productive cough

Inflammatory diseases of Rhinopharyngeal tract (e.g. Laryngitis, Pharyngitis, Sinusitis and Rhinitis)          

Asthmatic bronchitis, Bronchial asthma with difficult departure of mucus

Bronchiectasis

Chronic pneumonia

 

Dosage and Administration

Average daily dose (preferably after meal):

 

 

Side-effects

Gastrointestinal side-effects like epigastric pain, gastric fullness may occur occasionally. Rarely allergic responses such as eruption, urticaria or angioneurotic edema may occur.

 

Precautions

Ambroxol should be given cautiously to patients with gastric and duodenal ulceration or convulsive disorders. Patients with hepatic and renal insufficiency should take it with caution.

 

Use in Pregnancy and Lactation

Pregnancy: Teratogenic and fetal toxicity studies have shown no harmful effect of Ambroxol. However, it is advised not to use during pregnancy, especially in the 1st trimester.

Lactation: Safety during lactation has not been established yet.

 

Contraindications

Contraindicated in known hypersensitivity to Ambroxol or Bromhexine.

 

Drug Interactions

Ambroxol has no interaction with cardioactive glycosides, corticosteroids, bronchodilators, diuretics and antibiotics (normally used in the treatment of bronchopulmonary affections). But Ambroxol should not be taken simultaneously with antitussives (e.g. Codeine) because mucus, which has been liquefied by Ambroxol, might not be expectorated.

 

Commercial Pack

Onecof Syrup: Each PET bottle contains 100 ml syrup and a measuring cup.

 

 

 

Sunday, 16 October 2016 03:11

NX-1

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NX-1

(Naproxen)

 

Presentation

NX-1 Tablet: Each enteric coated tablet contains Naproxen Sodium USP equivalent to Naproxen USP 500 mg.

 

Description

Naproxen is a nonsteroidal anti-inflammatory drug with analgesic and antipyretic properties. Naproxen works by reducing the levels of prostaglandins, chemicals that are responsible for pain, fever and inflammation. Naproxen blocks the enzyme that makes prostaglandins (cyclooxygenase), resulting in lower concentrations of prostaglandins. As a consequence, inflammation, pain and fever are reduced.

 

Indications and Uses

Naproxen is indicated for its anti-inflammatory and analgesic action in the treatment of rheumatoid arthritis, osteoarthritis (degenerative arthritis), ankylosing spondylitis, juvenile rheumatoid arthritis, acute gout, acute musculoskeletal disorders, post-operative pain and dysmenorrhoea. It is also indicated in the relief of mild to moderate pain, and for the treatment of tendonitis and bursitis.

 



Dosage and administration

Adults

For rheumatoid arthritis, osteoarthritis and ankylosing spondylitis

The usual dose is 500-1000 mg per day taken in 2 doses at 12 hours intervals after meals.

For acute gout

750 mg should be given initially, followed in 8 hours with 500 mg, and thereafter 250 mg at 12 hours intervals until the attack has passed.

For dysmennorhoea

500 mg should be given initially, followed by 250 mg at 6-8 hour intervals for up to 5 days.

For analgesia and acute muscular skeletal disorders

500 mg should be given initially, followed by 250 mg at 6-8 hour intervals.

Children over 5 years

For juvenile rheumatoid arthritis

10mg/kg/day given as 2 divided doses at 12 hour intervals.

 

Contraindications

The drug is contraindicated in patients who have had allergic reactions to Naproxen. It is also contraindicated in patients in whom aspirin or other nonsteroidal anti-inflammatory/analgesic drugs induce the syndrome of asthma, rhinitis, and nasal polyps. Both types of reactions have the potential of being fatal.

 

Precautions

Serious GI toxicity such as bleeding, ulceration, and perforation, can occur at any time, with or without warning symptoms, in patients treated chronically with NSAID therapy. Although minor upper GI problems, such as dyspepsia, are common, usually developing early in therapy, physicians should remain alert for ulcerations and bleeding in patients treated chronically with NSAIDs even in the absence of previous GI tract symptoms.

 

Side-effects

The most common side effects from Naproxen are rash, ringing in the ears, headaches, dizziness, drowsiness, abdominal pain, nausea, diarrhea, constipation, heartburn, fluid retention and shortness of breath. Naproxen also may cause stomach and intestinal bleeding and ulcers.

 

Use in pregnancy and lactation

Pregnancy: Pregnancy Category C.

Naproxen should be used during pregnancy only if the potential benefits justify the potential risks to the fetus.

Nursing mother: The Naproxen has been found in the milk of lactating women. Because of the possible adverse effects of prostaglandin-inhibiting drugs on neonates, use in nursing mothers should be avoided.

 

Drug interactions

Naproxen may increase the blood levels of lithium by reducing the excretion of lithium by the kidneys. Increased levels of lithium may lead to lithium toxicity.

Naproxen may reduce the blood pressure lowering effects of blood pressure medications.

When naproxen is used in combination with aminoglycosides (e.g., gentamicin) the blood levels of the aminoglycoside may increase. This may lead to more aminoglycoside-related side effects.

Individuals taking anticoagulants (e.g. Warfarin) should avoid naproxen because naproxen also thins the blood, and excessive blood thinning may lead to bleeding.

 

Overdosage

Naproxen overdosage may be characterized by drowsiness, heartburn, indigestion, nausea, or vomiting. In animals 0.5 g/kg of activated charcoal was effective in reducing plasma levels of Naproxen. Hemodialysis does not decrease the plasma concentration of Naproxen.

 

Commercial pack

NX-1 Tablet: Each box contains 3 blister strips of 10 tablets.

Sunday, 16 October 2016 03:04

Nevrona

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Nevrona

(Vitamin B1, B6 & B12)

 

Presentation

Nevrona tablet: Each tablet contains Thiamine Mononitrate BP (100 mg), Pyridoxine Hydrochloride BP (200 mg), Cyanocobalamin BP (200 mcg).

 

Description

Nevrona is a special preparation of vitamin B1, B6 and B12. The vitamins B1, B6 and B12 are indispensable for a normal course of the nervous metabolism.

 

 

 

Indication & Uses

Nevrona is indicated for the treatment of B1, B6 and B12 deficiency syndrome. It is also indicated in  the treatment of:

 

 

Dosage and Administration

Tablets may be administered in a dose of 1 to 3 tablets per day or as directed by the physician.

 

Side Effects

Generally well tolerated. However, a few allergic reactions may be seen.

 

Precautions

Cyanocobalamin should not be given before a diagnosis has been fully established because of the possibility of masking symptoms of subacute degeneration of the spinal cord. Cyanocobalamin is not a suitable form of Vitamin B12 for the treatment of optic neuropathies associated with raised plasma concentrations of cyanocobalamin.

 

Use in pregnancy & lactation

Oral tablet form is recommended but injectable preparation is not recommended due to presence of benzyl alcohol.

 

Contraindications

Should not be used in the patients on Levodopa therapy and hypersensitivity to any of the active ingredients.

 

Drug Interactions

No such drug interactions have been reported.

 

Overdosage

If there is known overdose then treatment is symptomatic and supportive.

 

Commercial Pack

Nevrona Tablet: Each box contains 3 blister strips of 10 tablets.

Sunday, 16 October 2016 02:54

Dantron

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Dantron

(Ondansetron)

 

Presentation

Dantron Tablet: Each film coated tablet contains Ondansetron Hydrochloride Dihydrate BP 9.977 mg equivalent to Ondansetron 8 mg.

Dantron Syrup: Each 5 ml syrup contains Ondansetron Hydrochloride Dihydrate BP equivalent to Ondansetron 4 mg.

 

Description

Ondansetron is a selective 5-HT3 receptor antagonist. While its mechanism of action has not been fully characterized, Ondansetron is not a dopamine-receptor antagonist. Serotonin receptors of the 5-HT3 type are present both peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema. It is not certain whether Ondansetron's antiemetic action is mediated centrally, peripherally, or in both sites. However, cytotoxic chemotherapy appears to be associated with release of serotonin from the enterochromaffin cells of the small intestine.

 

Indications and Uses

1. Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including Cisplatin ≥ 50 mg/m2

2. Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy

3. Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen

4. Prevention of post-operative nausea and/or vomiting

5. Nausea-vomiting associated with pregnancy

6. Nausea-vomiting associated with gastroenteritis

 

Dosage and Administration

 

Contraindications

Ondansetron is contraindicated for patients known to have hypersensitivity to the drug.

 

Precautions

Ondansetron is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction. The use of Ondansetron in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distension.

 

Side-effects

Generally Ondansetron is well tolerated. However few side effects including headache, diarrhoea, fatigue, dizziness and constipation may be seen after Ondansetron is administered.

 

Use in pregnancy & lactation 

Pregnancy: Pregnancy category B.

Nursing mother: It is not known whether Ondansetron is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ondansetron is administered to a nursing woman.

 

Drug Interactions

The following drugs should be used with caution when concomitantly used with Ondansetron:

Phenytoin, Carbamazepine, Rifampicin & Tramadol.

 

Overdosage

There is no specific antidote for Ondansetron overdose. Hypotension (and faintness) occurred in a patient that took 48 mg of Ondansetron tablets.

 

Commercial Pack

Dantron Tablet: Each box contains 3 blister strips of 10 tablets.

Dantron Syrup: Each bottle contains 50 ml Syrup.

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

Written by

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.

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