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Tuesday, 24 April 2018 11:46

Sharpkil Plus

Sharpkil Plus

Cefuroxime + Clavulanic Acid

 

Presentation

Sharpkil Plus 250/62.5 Tablet: Each tablet contains Cefuroxime Axetil USP equivalet to Cefuroxime 250 mg and diluted Potassium Clavulanate BP equivalent to Clavulanic Acid 62.5 mg.

Sharpkil Plus 500/125 Tablet: Each tablet contains Cefuroxime Axetil USP equivalet to Cefuroxime 500 mg and diluted Potassium Clavulanate BP equivalent to Clavulanic Acid 125 mg.

 

 

Description

Cefuroxime is one of the bactericidal second generation cephalosporin antibiotics, which is active against a wide range of Gram-positive and Gram-negative susceptible organisms including many b-lactamase producing strains. It is indicated for the treatment of infections caused by sensitive bacteria.

 

Clavulanic acid has a similar structure to the beta-lactam antibiotics but binds irreversibly to the beta-lactamase enzymes. 

 

The presence of clavulanic acid in Sharpkil Plus formulations protects Cefuroxime from degradation by beta-lactamase enzymes and effectively extends the antibacterial spectrum of Cefuroxime to include many bacteria normally resistant to Cefuroxime and other cephalosporins.

 

 

Indications and Uses

>> Pharyngitis/tonsillitis caused by Streptococcus pyogenes

>> Acute bacterial otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta lactamase-producing strains), Moraxella Catarrhalis (including beta-lactamase-producing strains) or Streptococcus pyogenes

>> Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non-beta-lactamase-producing strains only)

>> Lower respiratory tract infections including pneumoniae, caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta lactamase-producing strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, Escherichia coli

>> Acute bacterial exacerbations of chronic bronchitis and secondary bacterial infections of acute bronchitis caused by Streptococcus penumoniae, Haemophilus influenzae (beta-lactamase negative strains) or Haemophilus parainfluenzae (beta-lactamase negative strains)

>> Skin and Skin-Structure Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, Escherichia coli, Klebsiella spp. and Enterobacter spp.

>> Urinary tract infections caused by Escherichia coli or Klebsiella pneumoniae

>> Bone and Joint Infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains)

>> Gonorrhea: Uncomplicated and disseminated gonococcal infections due to Neisseria gonorrhoeae (penicillinase- and non-penicillinase-producing strains) in both males and females

>> Early Lyme disease (erythema migrans) caused by Borrelia burgdorferi

>> Septicemia caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae (including ampicillin-resistant strains), and Klebsiella spp.

>> Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin resistant strains), Neisseria meningitidis and Staphylococcus aureus (penicillinase and non-penicillinase producing strains)

>> Switch therapy (injectable to oral) after surgery when patient’s condition is improved

 

Dosage and Administration

 

 

Sharpkil Plus may be administered without regard to meals.

 

Side-Effects

Generally Cefuroxime and Clavulanic acid are well tolerated. However, a few side effects like nausea, vomiting, diarrhea, abdominal discomfort or pain may occur. As with other broad-spectrum antibiotics, prolonged administration of Cefuroxime and Clavulanic acid combination may result in overgrowth of nonsusceptible microorganisms. Rarely (<0.2%) renal dysfunction, anaphylaxis, angioedema, pruritis, rash and serum sickness like urticaria may appear.

 

Precautions

Cefuroxime and Clavulanic Acid should be given with care to patients receiving concurrent treatment with potent diuretics & who have history of colitis.

 

Use in Pregnancy & Lactation

During pregnancy: While all antibiotics should be avoided in the first trimester if possible. However, Cefuroxime and Clavulanic Acid can be safely used in later pregnancy to treat urinary and other infections.

During lactation: Cefuroxime and Clavulanic Acid is excreted into the breast milk in small quantities. However, the possibility of sensitizing the infant should be kept in mind.

 

Contraindications

Patients with known allergy to cephalosporins & pseudomembranous colitis are contraindicated.

 

Drug Interactions

Concomitant administration of probenecid with Cefuroxime and Clavulanic Acid increases the area under the serum concentration versus time curve by 50%. Drug that reduces gastric acidity may result in a lower bioavailability of Cefuroxime and tend to cancel the effect of postprandial absorption.

 

Overdosage

Signs and symptoms: Overdosage of Cefuroxime and Clavulanic can cause cerebral irritation leading to convulsions.

Management: Serum levels of Cefuroxime and Clavulanic can be reduced by haemodialysis and peritoneal dialysis.

 

Storage

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

 

Commercial Pack

Sharpkil Plus 250/62.5 Tablet: Each box contains 7 tablets in 2 Alu-Alu blister within 2 Alu-Alu pouch pack.

Sharpkil Plus 500/125 Tablet: Each box contains 7 tablets in Alu-Alu blister within Alu-Alu pouch pack.

Tuesday, 24 April 2018 11:34

Pileus

Pileus

Fluconazole

 

Presentation

Pileus 50: Each capsule contains Fluconazole USP 50 mg.

Pileus 150: Each capsule contains Fluconazole USP 150 mg.

 

Description

Fluconazole is a synthetic triazole antifungal drug that inhibits the biosynthesis of ergosterol, a major component of the cell membrane of yeast and fungal cells, leading to abnormalities in membrane permeabilities, inhibition of growth, abnormal cell wall formation and accumulation of intracellular lipids and membranous vesicles. It is active against a broad spectrum of yeast and other fungal pathogens. Following oral administration, absorption is rapid with > 90% of the dose being absorbed. Bioavailability is the same whether taken during fasting or with food, as the pharmacokinetics of Fluconazole is relatively insensitive to physiological changes in the GIT. Unlike other azole drugs, the bioavailability of Fluconazole is unaffected by gastric pH so it can be given during treatment with antiulcer drugs including PPI. 80% of a dose of Fluconazole is excreted unchanged and 11% is excreted as inactive metabolites in the urine, presumably as a result of metabolism in the liver. A further 2% of a dose is recovered unchanged in the feces, and the fate of the remaining is unknown.

 

Indications

  >>Superficial candidal infections such as oral or vaginal thrush

  >>Esophagitis caused by Candida or other susceptible species

  >>Maintenance therapy of cryptococcal meningitis

  >>Disseminated candidiasis

  >>Prophylaxis for fungal infection in neutropenic cancer patients

  >>Acute treatment of other systemic fungal infections

  >>Dermatophyte and Candida skin infections

  >>Fungal UTIs

 

Dosage and administration

Fluconazole is usually given orally. Generally the total daily dose is given at once unless nausea supervenes, in which case the dose may be divided.

>> Vaginal candidiasis and candidal balanitis, by mouth, a single dose of 150 mg.

 >> Mucosal candidiasis (except genital), by mouth, 50 mg daily (100 mg daily in usually difficult infections) given for 7-14 days in oropharyngeal candidiasis; for 14-30 days in other mucosal infections (e.g. oesophagitis, candiduria, non-invasive bronchopulmonary infections); Child by mouth 3-6 mg/kg on 1st day then 3 mg/kg daily (every 72 hours in neonate up to 2  weeks old and every 48 hours in neonate 2-4 weeks old).

>>Tinea pedis, corporis, cruris, pityriasis versicolor, and dermal candidiasis, by mouth, 50 mg daily for 2-4 weeks (for up to 6 weeks in tinea pedis); maximum duration of treatment 6 weeks.

>> Invasive candidal infections including candidaemia and disseminated candidiasis and cryptococcal infections including meningitis, by mouth, 400 mg initially then 200 mg daily, increased if necessary to 400 mg daily, treatment continued according to response (at least 6-8 weeks for cryptococcal meningitis); Child 6-12 mg/kg daily (every 72 hours in neonate up to 2 weeks old, every 48 hours in neonate 2-4 weeks old); maximum 400 mg daily.

>> Prevention of relapse of cryptococcal meningitis, by mouth, 100-200 mg daily.

>> Prevention of fungal infections in immunocompromised patients following cytotoxic chemotherapy or radiotherapy, by mouth 50-400 mg daily adjusted according to risk; Child according to extent and duration of neutropenia, 3-12 mg/kg daily (every 72 hours in neonate up to 2 weeks old, every 48 hours in neonate 2-4 weeks old); maximum 400 mg daily.

 

Side effects

Nausea, abdominal discomfort, diarrhoea, flatulence, headache, rash; less frequently dyspepsia, vomiting, abnormalities in liver enzymes, seizures, alopecia and Stevens Johnson syndrome reported.

 

Precautions

Cautions should be taken in renal impairment; in hepatic disease liver function should be monitored and should be discontinued if signs or symptoms of hepatic disease appear.

 

Use in pregnancy and lactation

Pregnancy: There are limited data on the use of Fluconazole in pregnant woman. However Fluconazole should be used in pregnancy only when the benefit clearly outweighs the risk.

 

Lactation: Fluconazole is excreted in breast milk in levels about half of those found in plasma. Therefore, the drug should be avoided during lactation.

 

Contraindications

>> Known hypersensitivity

>> Advanced liver disease

 

Drug interactions

Fluconazole decreases the metabolism of Cyclosporine and Phenytoin and increases the AUC of Retinoic acid. Fluconazole increases bleeding time in patients treated with Warfarin. Concomitant use of Fluconazole decreases in the mean plasma clearance of Theophyllin and increases the plasma levels of Zidovudine and concentration of Oral hypoglycemics. Rifampin induces the metabolism of Fluconazole.

 

Over dosage

In the case of an overdose, supportive measures should be instituted.

 

Commercial pack

Pileus 50: Each box contains 2 blister strips of 10 capsules.

Pileus 150: Each box contains 1 blister strip of 10 capsules.

Tuesday, 24 April 2018 11:15

Onvas

Onvas

Atorvastatin

 

Presentation

Onvas 10 Tablet: Each film coated tablet contains Atorvastatin Calcium Trihydrate USP equivalent to Atorvastatin 10 mg.

Onvas 20 Tablet: Each film coated tablet contains Atorvastatin Calcium Trihydrate USP equivalent to Atorvastatin 20 mg.

 

Description

Atorvastatin is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.

 

Indications and usage

Atorvastatin is indicated as an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and triglycerides (TG) levels and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia; as an adjunct to diet for the treatment of patients with elevated serum triglycerides (TG) levels; for the treatment of patients with primary dysbetalipoproteinemia who do not respond adequately to diet; to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (eg, LDL apheresis) or if such treatments are unavailable.

 

Prior to initiating therapy with atorvastatin, secondary cause for hypercholesterolemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephritic syndrome, dysproteinemia, obstructive liver disease, other drug therapy, and alcoholism) should be identified and treated.

 

Dosage and administration

The patient should be placed on a standard cholesterol-lowering diet before receiving Atorvastatin and should continue on this diet during treatment with Atorvastatin. The recommended starting doses are 10 mg, 20 mg or 40 mg. The 40 mg dose is recommended for patients who require a reduction in LDL-cholesterol of more than 45 percent. Therapy for patients requiring further reductions can be adjusted up to the 80 mg dose. Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia: The recommended starting dose of Atorvastatin is 10 mg once daily. The dosage range is 10 to 80 mg once daily. Atorvastatin can be administered as a single dose at any time of the day, with or without food. Therapy should be individualized according to goal of therapy and response. After initiation and/or upon titration of Atorvastatin, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly. Since the goal of treatment is to lower LDL-C, the LDL-C levels should be used to initiate and assess treatment response. Only if LDL-C levels are not available, should total-C be used to monitor therapy. Homozygous Familial Hypercholesterolemia: The dosage of Atorvastatin in patients with homozygous FH is 10 to 80 mg daily. Atorvastatin should be used as an adjunct to other lipid-lowering treatments (eg, LDL apheresis) in these patients or if such treatments are unavailable. Concomitant Therapy: Atorvastatin may be used in combination with a bile acid binding resin for additive effect. The combination of HMG-CoA reductase inhibitors and fibrates should generally be avoided. Dosage in Patients With Renal Insufficiency: Renal disease does not affect the plasma concentrations nor LDL-C reduction of atorvastatin; thus, dosage adjustment in patients with renal dysfunction is not necessary. Pediatric Use: Treatment experience in a pediatric population is limited to doses of Atorvastatin up to 80 mg/day for 1 year in 8 patients with homozygous FH. No clinical or biochemical abnormalities were reported in these patients. None of these patients was below 9 years of age. Geriatric Use: Treatment experience in adults age  70 years with doses of Atorvastatin up to 80 mg/day has been evaluated in 221 patients. The safety and efficacy of Atorvastatin in this population were similar to those of patients <70 years of age.

 

Side effects

Atorvastatin is generally well tolerated. Adverse reactions have usually been mild and transient. In controlled clinical studies of 2502 patients, <2% of patients were discontinued due to adverse experiences attributable to atorvastatin. The most frequent adverse events thought to be related to atorvastatin were constipation, flatulence, dyspepsia, and abdominal pain.

 

Precaution

Before instituting therapy with atorvastatin, an attempt should be made to control hypercholesterolemia with appropriate diet, exercise, and weight reduction in obese patients, and to treat other underlying medical problems. Information for Patients: Patients should be advised to report promptly unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever.

 

Use in Pregnancy and Lactation

Since HMG-Co A reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, they may cause fetal harm when administered to pregnant women. Therefore, HMG-Co A reductase inhibitors are contraindicated during pregnancy and in nursing mothers. Atorvastatin should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards. If the patient becomes pregnant while taking this drug, therapy should be discontinued and the patient apprised of the potential hazard to the fetus. Because of the potential for adverse reactions in nursing infants, women taking atorvastatin should not breast-feed.

 

Contraindications

Hypersensitivity to any component of this medication. Active liver disease or unexplained persistent elevations of serum transaminases.

 

Drug interactions

The risk of myopathy during treatment with drugs of this class is increased with concurrent administration of cyclosporine, fibric acid derivatives, niacin (nicotinic acid), erythromycin, azole antifungals. When atorvastatin and antacid suspension containing magnesium and aluminum hydroxide were co-administered, plasma concentrations of atorvastatin decreased approximately 35%. However, LDL-C reduction was not altered. Plasma concentrations of atorvastatin decreased approximately 25% when colestipol and atorvastatin were co-administered. However, LDL-C reduction was greater when atorvastatin and colestipol were co-administered than when either drug was given alone. When multiple doses of atorvastatin and digoxin were co-administered, steady state plasma digoxin concentrations increased by approximately 20%. Patients taking digoxin should be monitored appropriately. In healthy individuals, plasma concentrations of atorvastatin increased approximately 40% with co-administration of atorvastatin and erythromycin. Co-administration of atorvastatin and an oral contraceptive increased AUC values for norethindrone and ethinylestradiol by approximately 30% and 20%. These increases should be considered when selecting an oral contraceptive for a woman taking atorvastatin.

 

Overdose

There is no specific treatment for atorvastatin overdose. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required. Due to extensive drug binding to plasma proteins, hemodialysis is not expected to significantly enhance atorvastatin clearance.

 

Storage

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

 

Commercial pack

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

Onvas 20 Tablet: Each box contains 2 blister strips of 10 tablets.

Tuesday, 24 April 2018 11:09

Onlac

Onlac

Lactulose

 

Presentation

Onlac 100 ml: Each 5 ml concentrated oral solution contains Lactulose USP 3.35 gm.

Onlac 200 ml: Each 5 ml concentrated oral solution contains Lactulose USP 3.35 gm.

 

Description

Lactulose is a semi-synthetic disaccharide used in the treatment of constipation and hepatic encephalopathy. It consists of the monosaccharides fructose and galactose. In the colon, lactulose is broken down primarily to lactic acid and also to small amounts of formic and acetic acids, by the action of ß-galactosidase from colonic bacteria, which results in an increase in osmotic pressure and slight acidification of the colonic contents. This in turn causes an increase in stool water content and softens the stool. In treating hepatic diseases (hepatic encephalopathy), lactulose draws out ammonia from the body in the same way that it draws out water into the colon.

 

Indication

1. Constipation (chronic constipation)

2. Hepatic encephalopathy (HE): treatment and prevention of hepatic coma or precoma

3. Intestinal flora disturbances: In damage to intestinal flora, following therapy with broad        spectrum antibiotics, gall bladder diseases and intestinal diseases (colitis, diverticulitis,                 megacolon etc.)

4. Increased blood ammonia levels (hyperammoniemia in hepatopathy, portal systemic            encephtopathy, precoma and coma)

 

Dosage & Administration

1. Constipation:

Adults: (including the elderly): 15 ml twice daily.

Children: 5 to 10 years: 10 ml twice daily.

Children under 5 years: 5 ml twice daily.

Babies under 1 year: 2.5 ml twice daily. Onlac solution may, if necessary, be taken with water or fruit juice, etc.

2. Hepatic encephalopathy:

Adults (including the elderly): Initially 30-50 ml three times a day. Subsequently adjust the dose to produce two or three soft stools each day.

Children: No dosage recommended for this indication.

3. In damaged intestinal flora (e.g. following long-term antibiotic treatment):

Adults: 5-10 ml daily.

Children: 5 ml daily.

4. To reduce blood ammonia level (In hepatopathy):

A maximum of 60-100 g lactulose daily.

 

Side-effects

Initial dosing may produce flatulence and intestinal cramps, which are usually transient. Nausea, vomiting and abdominal pain may occur. Excessive dosage can lead to diarrhoea.

 

Precautions

It should be used with caution in patients with lactose intolerance and diabetes.

 

Use in Pregnancy and Lactation

Pregnancy

Pregnancy Category B. Lactulose oral solution has been shown to be safe and effective for the treatment of constipation associated with pregnancy when administered to women at different stages of pregnancy.

Lactation

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when lactulose is administered to a nursing woman.

 

Contraindications

Lactulose is contraindicated in patients with galactosaemia and intestinal obstruction.

 

Drug Interactions

Nonabsorbable antacids given concurrently with lactulose may inhibit the desired lactulose-induced drop in colonic pH. Therefore, a possible lack of desired effect of treatment should be taken into consideration before such drugs are given concomitantly with lactulose.

 

Overdosage

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

 

Storage

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

 

Commercial Pack

Onlac 100 ml: Each amber PET bottle contains 100 ml oral solution with a measuring cup.

Onlac 200 ml: Each amber PET bottle contains 200 ml oral solution with a measuring cup.

 

Tuesday, 24 April 2018 09:22

Ocimax PFS

Ocimax

Ciprofloxacin

 

Presentation

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

Ocimax Suspension: Each 5 ml suspension contains Ciprofloxacin USP 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 Suspension: Each pet bottle containing 60 ml pellets for suspension.

Tuesday, 24 April 2018 09:15

Murein

Murein

Flucloxacillin

Presentation

Murein 500: Each capsule contains Flucloxacillin Sodium BP equivalent to Flucloxacillin 500 mg.

 

Description

Flucloxacillin is a narrow-spectrum antibiotic with considerable activity against the following common Gram-positive organisms:

>>Penicillinase producing Staphylococcus aureus

>>Penicillinase sensitive Staphylococcus aureus

>>ß-haemolytic streptococci (Streptococcus pyogenes)

>>Streptococcus pneumoniae

It has little activity against Gram-negative bacilli. However, the Gram-negative organisms Neisseria gonorrhoeae and Neisseria meningitidis come within the range of activity. Flucloxacillin kills bacteria by inhibiting the formation of cell wall of bacteria.

 

Indications and Uses

>>Skin and Soft Tissue Infections: Boils, abscesses, carbuncles, furunculosis, infected  wounds, infected burns, protection of skin grafts, otitis media and externa, impetigo.

>>Infected Skin Conditions: Ulcer, eczema and acne.

>>Respiratory Tract Infections: Pneumonia, lung abscess, empyema, sinusitis, pharyngitis, tonsillitis, quinsy.

>>Other infections caused by  Flucloxacillin-sensitive organisms such as osteomyelitis, enteritis, endocarditis, urinary tract infection, meningitis, septicaemia.

 

Flucloxacillin is also indicated for use as a prophylactic agent during major surgical procedures where appropriate, for example, cardiothoracic and orthopaedic surgery.

 

Dosage

Adults (including elderly patients): 

Oral:

500 mg three to four times a day. Oral doses should be administered 1 hour before meal.

 

Children

2-10 years: Half of adult dose.

Under 2 years: One fourth of adult dose.

Children have been given doses of 12.5mg/kg body weight four times a day.

 

Patients with impaired renal function:

As common with other penicillins, Flucloxacillin usage in patients with renal impairment does not usually require dosage reduction. However, in the presence of severe renal failure (creatinine clearance<10 ml/min) a reduction in dose or an extension of dosage interval should be considered.

 

 

 

 

Side effects

There have been some common side effects of GIT such as nausea, vomiting, diarrhoea, dyspepsia and other minor gastrointestinal disturbances. Besides these rashes, urticaria, purpura, fever, interstitial nephritis, hepatitis and cholestatic jaundice have been reported.

 

Contraindications 

Flucloxacillin should not be given to penicillin-hypersensitive patients.

 

Use in pregnancy

Penicillins are generally considered safe for use in pregnancy. Animal studies with Flucloxacillin have shown no teratogenic effect.

 

Use in lactation

Flucloxacillin is excreted in breast milk in trace amounts. Flucloxacillin may be administered during the period of lactation.

 

Overdosage

Although overdosage problems are unlikely to occur with penicillins, and should be treated symptomatically.

 

Commercial Pack

Murein 500: Each box contains 7 strips of 4 capsules.

Tuesday, 24 April 2018 09:11

Kelorac Injection

Kelorac

 

Presentation

Kelorac 30 IM/IV injection: Each ampoule contains Ketorolac Tromethamine USP 30 mg.

 

Description

Ketorolac Tromethamine is a drug of pyrrolo-pyrrole group of nonsteroidal anti-inflammatory 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 (1:1). 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 moderately severe acute pain that requires analgesia at the opioid level, (usually in postoperative setteing). Therapy should always be started with Ketorolac Tromethamine IM/IV injection and Ketorolac Tromethamine oral is to be used only as continuation treatment, if necessary. Combined use of Ketorolac Tromethamine IM/IV and oral is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses.

 

Dosage and Administration

Kelorac injection

Ketorolac Tromethamine injection may be used as a single or multiple doses, on a regular or when necessary schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. When administering Kelorac injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins in ~30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.

 

Single-Dose Treatment:  The following regimen should be limited to single administration use only.

Adult Patients:

IM Dosing: Patients < 65 years of age: One dose of 60 mg. Patients > 65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 30 mg.

IV Dosing: Patients < 65 years of age: One dose of 30 mg. Patients > 65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 15 mg.

 

Pediatric Patients (2 to 16 years of age):

IM Dosing: One dose of 1 mg/kg up to a maximum of 30 mg.

IV Dosing: One dose of 0.5 mg/kg up to a maximum of 15 mg.

 

Multiple-Dose Treatment (IV or IM):

Patients <65 years of age: The recommended dose is 30 mg Kelorac injection every 6 hours. The maximum daily dose should not exceed 120 mg. Patients ≥ 65 years of age, renally impaired patients, and patients less than 50 kg : The recommended dose is 15 mg Kelorac injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg. For breakthrough pain, do not increase the dose or the frequency of Ketorolac Tromethamine.

 

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.

Gastrointestinal side-effects include abdominal discomfort, constipation, diarrhea, dyspepsia, flatulence, fullness, gastritis, gastrointestinal bleeding, gastrointestinal pain, nausea, pancreatitis, peptic ulcer, perforation, stomatitis, vomiting etc.

 

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 disorders are contraindicated for this drug.

 

Precautions

Precaution should be taken in Elderly, Allergic disorder, Renal, cardiac & hepatic impairment,  Porphyria, Patient with low body weight (≤50kg).

 

Use in pregnancy & lactation

Pregnancy category C. Ketorolac Tromethamine is contraindicated in pregnancy and lactation.

 

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 30 IM/IV injection: Each box contains 1 ampoule in blister pack and a 3 ml sterile disposable syringe.

Tuesday, 24 April 2018 09:07

Dometic Tablet

Dometic

Domperidone

 

Presentation

Dometic Tablet: Each film coated tablet contains Domperidone Maleate BP equivalent to Domperidone 10 mg.

Dometic Suspension: Each 5 ml contains Domperidone BP 5 mg.

 

Description

Dometic is a Dopamine antagonist .Because it does not readily enter the central nervous system, its effects are confined to the periphery and acts principally at the receptor in the chemoreceptor trigger zone.

 

Indications

1. Stimulation of gut mobility

  a) Non-ulcer dyspepsia

  b) Esophageal reflux, reflux esophagitis and gastritis

  c) Diabetic gastroparesis

  d) Functional dyspepsia

  e) Speeding barium transit in 'follow-through' radiological studies

2. Prevention and symptomatic relief of acute nausea and vomiting from any cause                   

    including cytotoxic therapy, radio therapy and anti-parkinsonism therapy

3. In the treatment of migraine.

 

Dosage and Administration

The recommended oral dose for

Adults : 10 - 20 mg every 4 - 8 hours daily

Children : 0.2 - 0.4 mg/kg every 4 - 8 hours daily.

Note : Domperidone tablet and suspension should be taken 15 - 30 minutes before a meal. 

For acute nausea and vomiting, maximum period of treatment is 12 weeks.

 

Contraindications

Domperidone is contraindicated to patients who have known hypersensitivity to this drug and in case of neonates.

 

Precautions

Domperidone should be used with absolute caution in case of children because there may be an increased risk of extra-pyramidal reactions in young children because of an incompletely developed blood-brain barrier.

 

Side-effects

Domperidone may produce hyperprolactinemia(1.3% frequency). This may result in galactorrhea, breast enlargement and soreness and reduced libido. Dry mouth (1.9%), thirst, headache (1.2%), nervousness, drowsiness (0.4%), diarrhea (0.2%), skin rash and itching (0.1%) may occur during treatment with Domperidone. Extra-pyramidal reactions are seen in 0.05% of patients in clinical studies.

 

Use in Pregnancy & Lactation 

Pregnant women : The safety of Domperidone has not been proven and it is therefore not recommended during pregnancy.Animal studies have not demonstrated teratogenic effects on the fetus.

Lactating mother : Domperidone may precipitate galactorrhea and improve post-natal lactation. It is secreted in breast milk but in very small quantities insufficient to be considered harmful.

 

Drug interactions

Domperidone may reduce the hypoprolactinemic effect of bromocriptine. The action of Domperidone on GI function may be antagonized by anti-muscarinics and opioid analgesics.

 

Overdosage 

There are no reported cases of  overdosage.

 

Commercial Pack

Dometic Tablet: Each box contains 10 blister strips of 10 Tablets.

Dometic Suspension: Each bottle contains 60 ml of Suspension.

Tuesday, 24 April 2018 09:03

Dometic Suspension

 

Dometic

Domperidone

 

Presentation

Dometic Tablet: Each film coated tablet contains Domperidone Maleate BP equivalent to Domperidone 10 mg.

Dometic Suspension: Each 5 ml contains Domperidone BP 5 mg.

 

Description

Dometic is a Dopamine antagonist .Because it does not readily enter the central nervous system, its effects are confined to the periphery and acts principally at the receptor in the chemoreceptor trigger zone.

 

Indications

1. Stimulation of gut mobility

  a) Non-ulcer dyspepsia

  b) Esophageal reflux, reflux esophagitis and gastritis

  c) Diabetic gastroparesis

  d) Functional dyspepsia

  e) Speeding barium transit in 'follow-through' radiological studies

2. Prevention and symptomatic relief of acute nausea and vomiting from any cause                   

    including cytotoxic therapy, radio therapy and anti-parkinsonism therapy

3. In the treatment of migraine.

 

Dosage and Administration

The recommended oral dose for

Adults : 10 - 20 mg every 4 - 8 hours daily

Children : 0.2 - 0.4 mg/kg every 4 - 8 hours daily.

Note : Domperidone tablet and suspension should be taken 15 - 30 minutes before a meal. 

For acute nausea and vomiting, maximum period of treatment is 12 weeks.

 

Contraindications

Domperidone is contraindicated to patients who have known hypersensitivity to this drug and in case of neonates.

 

Precautions

Domperidone should be used with absolute caution in case of children because there may be an increased risk of extra-pyramidal reactions in young children because of an incompletely developed blood-brain barrier.

 

Side-effects

Domperidone may produce hyperprolactinemia(1.3% frequency). This may result in galactorrhea, breast enlargement and soreness and reduced libido. Dry mouth (1.9%), thirst, headache (1.2%), nervousness, drowsiness (0.4%), diarrhea (0.2%), skin rash and itching (0.1%) may occur during treatment with Domperidone. Extra-pyramidal reactions are seen in 0.05% of patients in clinical studies.

 

Use in Pregnancy & Lactation 

Pregnant women : The safety of Domperidone has not been proven and it is therefore not recommended during pregnancy.Animal studies have not demonstrated teratogenic effects on the fetus.

Lactating mother : Domperidone may precipitate galactorrhea and improve post-natal lactation. It is secreted in breast milk but in very small quantities insufficient to be considered harmful.

 

Drug interactions

Domperidone may reduce the hypoprolactinemic effect of bromocriptine. The action of Domperidone on GI function may be antagonized by anti-muscarinics and opioid analgesics.

 

Overdosage 

There are no reported cases of  overdosage.

 

Commercial Pack

Dometic Tablet: Each box contains 10 blister strips of 10 Tablets.

Dometic Suspension: Each bottle contains 60 ml of Suspension.

Tuesday, 24 April 2018 08:58

Caftyl

Caftyl

Paracetamol 500 mg & Caffeine 65 mg

 

Presentation

Caftyl: Each tablet contains Paracetamol BP 500 mg & Caffeine BP 65 mg.

 

Description

Caftyl (Paracetamol & Caffeine) 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. The presence of Caffeine increases the effectiveness of Paracetamol.

 

Indications

The indications of Caftyl are as follows

>>Headache

>>Migraine

>>Toothache

>>Neuralgia

>>Feverishness

>>Period pain

>>Sore throat

>>Rheumatic pain & backache

>>Helps to reduce temperature

>>Pain of colds and flu

 

Dosage and Administration

Adult: 1-2 tablets every 4-6 hours. Maximum dose 4 g (8 tablets) daily.

 

Side effects

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.

 

Precautions

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 with a physician should be avoided.

 

Contraindications

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

 

Use in pregnancy and lactation

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

 

Drug Interactions

Paracetamol & Caffeine increases the effect of chloramphenicol and coumarin anti-coagulant. Risk of hepatotoxicity of paracetamol may be increased in alcoholics or in patients taking other anti- epileptic medications.

 

Overdosage

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.

 

Commercial Pack

Caftyl: Each box contains 10 blister strips of 10 tablets.

 

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.

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