Xinc B

Xinc B
Zinc and vitamin B-complex tablet/syrup

DESCRIPTION
Xinc B is a preparation of Zinc Sulfate Monohydrate and vitamin B complex. It is composed of Zinc, Thiamine, Riboflavin, Pyridoxine and Nicotinamide

INDICATIONS
Xinc B is indicated for the treatment and prevention of Zinc and vitamin B deficiencies.

DOSAGE AND ADMINISTRATION
Children (under 10 kg)1 tablet or 1 teaspoonful (5 ml) daily after meal or as recommended by the registered physician 1 tablet or 1 teaspoonful (5 ml) 3 times daily after meal or as recommended by the registered physician 1-2 tablets or 1-2 teaspoonful (5-10 ml) 3 times daily after meal or as recommended by the registered physician Children (10-30 kg) Adults and children (over 30 kg)

CONTRAINDICATIONS
It is contraindicated in individual known to be hypersensitive to any of its active ingredients

PRECAUTIONS
in acute renal failure zinc accumulation may occur, so dosage adjustment is needed. It is not intended for treatment of severe specific deficiencies

SIDE EFFECTS
Xinc B is generally well tolerated. However, a few side effects like nausea, vomiting, diarrhea, stomach upset may occur. Side effects have been reported with specific vitamins but generally at levels substantially higher than those available in Xinc B

DRUG INTERACTIONS
Concomitant Intake of a tetracycline and zinc may decrease the absorption of both the tetracycline and zina. Similarly concomitant administration of zinc and quinolone may also decrease the absorption of both. Concomitant intake of penicillamine and zinc may depress absorption of zinc. As liftle as 5 mg pyrldoxine daily can decrease the efficiency of levodopa in the treatment of parkinsonism.

USE IN PREGNANCY AND LACTATION
Xinc B can be used in pregnancy and lactation

OVERDOSAGE
Symptoms of overdose may include severe nausea, vomiting dizziness, convulsions and coma after apparent recovery. In case of overdose one should seek emergency medical attention

PHARMACEUTICAL PRECAUTION
Store in a dry place and away from light. Keep out of reach of children

PACKAGING
XTneB® Tablet-Bottle containing 30 tablets each. Each Tablet contains Zinc Sulfate Monohydrate USP equivalent to elemental Zinc 10 mg, Thiamine Mononitrate USP 5 mg, Riboflavin USP 2 mg, Pyridoxine Hydrochloride USP 2 mg, Nicotinamide USP 20 mg.

Xinc B Syrup: Bottle containing 100 ml / 200 ml syrup. Each 5 ml syrup contains Zinc Sulfate Monohydrate USP uquivalent to elemental Zinc 10 mg, Thiamine Hydrochloride USP 5 mg, Riboflavin 5'-phosphate Sodium USP equivalent to Riboflavin 2 mg. Pyridoxine Hydrochloride USP 2 mg, Nicotinamide USP 20 mg

Manufactured by
SKF BANGLADESH LIMITED
BANGLADESH
REGD.TRADEMARK
PM01550 V05

Trimethoprim BP

FISAT

Presentation

FISAT Tablets: White, scored, circular tablets engraved with ‘FISAT’; each tablet contains 80 mg

trimethoprim BP and 400 mg sulphamethoxazole BP. FISAT Suspension: White coloured, banana

flavoured suspension; each 5 ml suspension contains 40 mg trimethoprim BP and 200 mg

sulphamethoxazole BP.

Uses

FISAT is an antibacterial agent effective against a wide range of Gram-positive and Gram-negative organisms. It is indicated in: Respiratory tract infections: Acute and chronic bronchitis, bronchiectasis, lobar and bronchopneumonia, pneumocystis carinii pneumonitis, otitis media and sinusitis. Genito-urinary infections: Urethritis, cystitis, pyelitis, pyelonephritis, prostatitis, and male and female gonorrhoea. Gastro-intestinal infections:Typhoid and paratyphoid fever, chronic carriage of Salmonella typhi and paratyphi, cholera and shigellosis. Skin infections: Pyoderma, abscesses and wound infections. Other bacterial infections: Acute and chronic osteomyelitis, acute brucellosis, septicaemias and other infections caused by sensitive organisms.

Dosage and administration

Adults and children over 12 years: The usual daily dosage is 2 tablets twice daily at an interval of 12 hours. Maximum dosage: 3 tablets twice daily. Long-term treatment (more than 14 days): 1 tablet in the mornings, 1 tablet in the evenings. The tablets should be taken after meals with a little fluid. Children: Unless otherwise prescribed, children receive the following daily dosage.

Age	weight (kg)	Measuring spoon  (5ml )of suspension
6 weeks to 6 months.	4 to 7	½ spoonful twice daily
6 months to 6 years	8 to 20	1 spoonful twice daily
6 years to 12 years	20 to 40	2 spoonful twice daily

Specific dosage recommendations for adults: Acute uncomplicated urinary tract infections :A single dose of 4 tablets (1.92 g of co-trimoxazole). Gonorrhoea: In uncomplicated cases 4 tablets every 12 hours for two days or 5 tablets followed by a further dose of 5 tablets eight hours later. FISAT may also be used as prophylaxis of recurrent urinary tract infection in the following dosages: Adults and children over 12 years: 1 tablet nightly. Children under 12 years: A single nightly dose of 2 mg trimethoprim and 10 mg ulphamethoxazoie per kg body weight. Treatment may be continued for 3 to 12 months or more as suggested by the physician. Before using FISAT as a prophylactic agent, the urine needs to be sterilized by giving appropriate treatment of urinary tract infection. When renal performance is reduced the dosage must be adjusted to the renal function. In long-term therapy (longer than 14 days), the average daily dosage is halved. The suspension can be diluted with milk or fennel tea but not with acidic beverages e.g., fruit juices or mineral water containing carbonic acid. The duration of treatment depends on the response of the pathogen and the clinical picture in each case. Acute infections should be treated for at least 5 days or at least until the patient has been symptom-free for 2 days

Contra-indications, warnings, etc.

Contra-indications: Blood d to(als yscrasias. Hypersensitivity to sulphonamides (also consider allergy sulphonylurea antidiabetic agents and diuretic sulphonamide derivatives). Severe liver and kidney damage. Erythema multiforme-also in the patient’s medical history. Co-trimoxazole should not be given to premature or newborn babies or to infants under six weeks of age. It should not be administered in jaundice and also when conditions of vitamin B12 and folic acid deficiency exist. Use in pregnancy and lactation: Co-trimoxazole should not be given during pregnancy as folate antagonists may have teratogenic effects. Co-trimoxazole is unlikely to cause any harm to the normal infant, so can be given to lactating mothers if essential. Precautions: In long-term therapy (more than 14 days), regular checks on the blood picture, including thrombocyte counts, are indicated. Renal impairment necessitates a dosage reduction in order to avoid cumulation. In such cases, determinations of the plasma concentration of sulphamethoxazole should be carried out. This should not exceed 120 mcg/mi. In functional disorders of the thyroid gland, use should be subject to medical supervision. If symptoms such as sore throat, fever or influenza- like complaints occur during the treatment, then the blood picture should be checked immediately. Side-effects: In occasional cases, exanthema can occur as can also nausea, vomiting and diarrhea. Haematological changes have been observed particularly in elderly patients. The symptoms were generally slight and regressed upon withdrawal of the preparation. Thrombopenia leucopenia and neutropenia have been described, and more rarely megaloblastic anaemia, purpura or agranulocytosis. Drug interactions: During concomitant therapy with sulphonylureas, the hypoglycaemic effect can be enhanced. This should be taken into account when setting the dosage of these substances. Benzocaine, procaine and tetracaine can reduce the effect of the sulphonamide. The action of methotrexate and anticoagulants can be intensified. Because of FISATs sulphonamide component, simultaneous or alternating treatment with preparations containing hexamethylenetetramine should not be carried out. The same applies to and teas containing hexamethylenetetramine. Overdosage: Symptoms of acute overdosage are likely to be nausea, vomiting, abdominal pain, dizziness and confusion. Treatment should consist of gastric lavage if within an hour of ingestion, and may include forced diuresis. Hypersensitivity reactions may require treatment with steroids. Calcium folinate, 3 to 6 mg intramuscularly for five to seven days may be given to counteract the effect of trimethoprim on haemopoiesis.

Pharmaceutical precautions

Storage: FISAT tablets and suspension should be stored in a cool dry place protected from light.

Package quantities

FISAT Tablets: Cartons of 100 tablets in strip. FISAT Suspension: Bottles of 60 ml.

Cephradine BP

SEFRAD

Presentation

SEFRAD 250 mg Capsules: Light caramel and dark brown capsules imprinted with company logo and ‘SEFRAD 250 mg’; each capsule contains cephradine BP 250 mg. SEFRAD 500 mg Capsules: Caramel and black capsules imprinted with company logo and ‘SEFRAD 500 mg’; each capsule contains cephradine BP 500 mg. SEFRAD Syrup: Bottles containing powder for preparation of 100 ml of yellow coloured, banana flavoured syrup; when reconstituted each 5 ml contains cephradine BP 125 mg. SEFRAD 250 mg Injection: Powder in vials containing cephradine with arginine equivalent to 250 mg cephradine USP. SEFRAD 500 mg Injection: Powder in vials containing cephradine with arginine equivalent to 500 mg cephradine USP.

Microbiology

The wide range of micro-organisms that have shown ‘in vitro’ sensitivity to cephradine include:

Gram-positive	Gram-negative
Staphylococcus aureus	Escherichia coli
Staphylococcus epidermidis	Proteus mirabilis
Streptococcus pyogenes	Klebsiella spp
Streptococcus pneumoniae	Neisseria gonorrhoeae
Streptococcus viridans	Haemophilus influenzae
Streptococcus faecalis	Shigella spp
Peptococcus	Salmonella spp.
Peptostreptococcus	Gardnerella vaginalis

Cephradine is relatively more resistant to hydrolysis by beta-lactamases and hence many strains of both Gram-positive and Gram-negative bacteria capable of producing beta-lactamase are susceptible to cephradine but resistant to many other broad spectrum antibiotics.

Uses

SEFRAD is a broad spectrum bactericidal antibiotic of the cephalosporin group active against a wide range of infections caused by susceptible Gram-positive and Gram-negative organisms. SEFRAD is indicated for the treatment of the following bacterial infections: Upper respiratory tract, ENT infections: Pharyngitis, Tonsillitis, Laryngo-Tracheitis, Sinusitis, Otitis media. Lower respiratory tract infections: Acute and chronic bronchitis, Lobar and broncho-pneumonia. Urinary tract infections: Cystitis, Urethritis, Pyelonephritis, Prostatitis, Epididymitis. Skin and soft tissue infections: Abscess, Cellulitis, Furunculosis, lmpetigo. Gastro-intestinal tract infections: Bacillary dysentery, Enteritis, Peritonitis. Infections in the bones and joints. Septicaemia Endocarditis SEFRAD is also of value for the prophylaxis of post-operative infections, in patients undergoing surgical procedures associated with a high risk of infection. As in the case of any antimicrobial agent, before instituting therapy with cephradine, necessary bacteriological studies should be performed to identify the causative organisms and their sensitivity to cephradine.

Dosage and administration

Adults:

Oral: The usual dosage range is 1-2 gm daily in two or four equally divided doses. Severe or chronic infectiuns rnay require larger doses upto 4 gm daily in divided doses or as advised by the physician. Specific dosage recommendations: Respiratory tract infections: 250 mg to 500 mg four times daily or 500 mg to 1 g twice daily Urinary tract infections 500 mg four times daily or 1 g twice daily. Skin and soft tissue infections: 250 mg four times daily or 500 mg to 1 g twice daily. Gastro-intestinal tract infections 500 mg three to four times daily. Parenteral: The usual dosage range is 2-4 g daily, IM or IV in four equally divided doses. This may be increased up to 8 g a day for severe infections e.g. septicaemia and endocarditis.

Children:

Oral: The usual dose is 25 to 50 mg/kg/day, given in two or four equally divided doses. The oral dosages should be taken before meals. Parenteral The usual dose is 50-100 mg/kg/ day, given in four equally divided doses. More serious infections may require 200-300 mg/kg/ day. Elderly: There are no specific dosage recommendations or precautions for use in the elderly except, as with other drugs, to monitor those patients with impaired renal or hepatic functions. Larger oral doses (upto 1 gm four times daily) may be given to all patients, irrespective of age and weight, for chronic infections or depending on the severity or site of infections. Therapy should be continued for a minimum of 48-72 hours after the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. In infections caused by beta-haemolytic strains of streptococci, a minimum of 10 days treatment is recommended to guard against the risk of rheumatic fever or glomerulonephritis. In the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisal is necessary during therapy and may be necessary for several months afterwards.Persistent infections may require treatment for several weeks. Doses for children should not exceed doses recommended for adults.

Dosage in renal impairment:

A modified dosage schedule in patients with decreased renal function is necessary. Each patient should be considered individually; the following reduced dosage schedule is recommended as a guideline, based on the creatinine clearance (m/min/1.73 m2). In adults, the initial loading dose is 750 mg of SEFRAD and the maintenance dose is 500 mg at the following time intervals:

Creatinine clearance	Time interval
More than 20 m/min	6-12 hours
15-19 ml/min	12-24 hours
10-14 mlmin	40-50 hours
5-9 ml/min	50-70 hours
Less than 5 mlmin

Further modification of the dosage schedule may be necessary in children. Surgical prophylaxis: The recommended dose for surgical prophylaxis is a single pre-operative 1-2 im or iv dose.Subsequent parenteral or oral doses can be administered as appropriate.

Administration:

Oral: Using capsule or syrup.

Intramuscular:

250 mg: add 1.2 mi Water for Injection BP and shake vigorously.

500 mg : Add 2,0 ml Water for lnjection BP and shake vigorously.

Intravenous:

250 mg: Dissolve in 5 ml of Water for Injection BP.

500 mg: Dissolve in 5 ml of Water for Injection BP.

The solution may be slowly injected directly into a vein over a 3 to 5 minute period. Solutions should be used within 2 hours when kept at room temperature. When stored at 5° C, solutions retain potency for 12 hours. Reconstituted solutions may vary in colour from light to straw yellow; however this does not affect the potency.

Contra-indications, warnings, etc.

Contra-indications: SEFRAD is contra-indicated in patients with known hypersensitivity to the cephalosporin antibiotics. Precautions: There is evidence of partial cross allergenicity between the penicillins and the cephalosporins. Therefore cephradine should be used with caution in those patients with known hypersensitivity to penicillins. As with all antibiotics, prolonged use may result in overgrowth of non-susceptible organisms. A false positive reaction for glucose in the urine may occur with reducing substances but not with enzyme-based tests.Administration in renal failure : A modified dosage schedule in patients with decreased renal function is necessary (see dosage). Pregnancy and breast feeding: Animal studies with cephradine have shown no teratogenicity. When antibiotic therapy is indicated during pregnancy SEFRAD may be considered appropriate. Cephradine is excreted in breast milk and should be used with caution in lactating mothers. Side-effects: Side-effects are limited essentially to gastro-intestinal disturbances and on occasion to hypersensitivity phenomena. The latter are more likely to occur in individuals who have previously demonstrated hypersensitivity and those with a history of allergy, asthma, hay fever or urticarias. The majority of reported side-effects have been mild. Skin reactions have occasionally been reported. Adverse reaction reports are rare, but includeglossitis, heart burn, dizziness, tightness in the chest, nausea, vomiting, diarrhoea, abdominal pain, vaginitis, candidal overgrowth. Skin and hypersensitivity reactions include urticaria, skin rashes, joint pains and oedema. As with other cephalosporins, mild transient eosinophilia, eucopenia and neutropenia, positive direct Coombs test and pseudomembraneous colitis have been reported. Rarely have these side effects been severe enough to warrant cessation of therapy. As with other parenterally administered antibiotics, transient pain may be experienced at the injection site, but is seldom the cause for discontinuing treatment. Thrombophlebitis has been reported following intravenous injection. Since sterile abscesses have been reported following accidental subcutaneous injection, the preparation should be administered by deep intramuscular injection. Clinical chemistry: Isolated instances of mild elevations of BUN, SGOT, SGPT, total bilirubin and alkaline phosphatase have been observed, but in most cases, the values tend to return to normal at the end of the therapy. No consistent pattern was observed that would suggest hepatocellular damage.

Pharmaceutical precautions

Storage: SEFRAD capsules and dry powder for syrups should be stored in a cool place. SEFRAD syrup should be freshly prepared. Reconstituted syrup should be used within 7 days if kept at room temperature or within 14 days, if kept in a refrigerator. Solutions of cephradine should be protected from concentrated light or direct sunlight.

Package quantities

SEFRAD 250 mg capsules: cartons of 20 capsules in strip. Capsules SEFRAD 500 mg Capsules: cartons of 20 in strip. SEFRAD Syrup: Bottles containing powder to produce 100 ml of syrup when reconstituted. SEFRAD 250 mg injection: Cartons of 10 combipacks. Each combipack contains 1 vial of 250 mg and 1 ampoule of 5 ml Water for Injection BP for dilution.SEFRAD 500 mg Injection: Cartons of 10 combipacks. Each combipack contains 1 vial of 500 mg and 1 ampoule of 5 ml Water for Injection BP for dilution.

Ref. FISONS (BANGLADESH) LIMITED

Phenoxymethylpenicillin potassium BP

PEN-V

Presentation

PEN-V Tablets: White, scored, circular, tablet; each tablets; contains phenoxymethylpenicillin potassium BP equivalent to 250 mg phenoxymethylpenicillin. PEN-V Syrup: Bottles containing powder to produce 50 ml of red coloured, raspberry flavoured syrup; when reconstituted each 5 ml contains phenoxymethylpenicillin potassium BP equivalent to 125 mg phenoxymethylpenicillin.

Uses

PEN-V is highly active in a wide variety of infectious diseases caused by phenoxymethylpenicillin susceptible Gram-positive organisms. It is used in the management of infections due to phenoxymethylpenicillin-sensitive organisms in particular streptococci and staphylococci but also including pneumococci, treponema pallidum, clostridia and some strains of neisseria. It is recommended for the therapeutic use in the following conditions: Pneumococcal infections: Respiratory tract infection of mild to moderate severity and infection in the middle ear and paranasal sinuses. Streptococcal infections: Pharyngitis including scarlet fever, otitis media and sinusitis. Staphylococcal infections (except penicillinase- producing strains): Mild infections of the skin and soft tissue sensitive to penicillin. Fusospirochetal infections: Gingivitis and Pharyngitis. Prophylactic uses: It is found to be effective in preventing streptococcal infection in susceptible hosts. Also it has proved effective in preventing the recurrence of rheumatic fever and chorea.

Dosage and administration

Adults: 125 mg to 500 mg every four to six hours depending on the severity of the condition. Children: 5 to 12 years: 125 mg to 250 mg every four to six hours. 1 to 5 years: 125 mg every six hours. Infants: (upto 1 year): 62.5 mg every six hours. To prevent the recurrence of rheumatic fever doses of 125 mg every twelve hours may be given for a period as suggested by the physician. Ideally, each dose should be given half an hour before or at least three hours after a meal.

Contra-indications, warnings, etc

Contra-indications: Contra-indicated in patients known to be hypersensitive to any penicillin. Use in pregnancy and lactation: It is secreted in the breast milk and should be used with caution in nursing mothers as it may provoke allergic reactions in the offspring. PEN-V has been used during human pregnancy for many years with no evidence of any teratogenic effect. However, as with all drugs it should not be used during the first trimester unless essential. Warnings: Hypersensitivity reactions are likely to occur in patients with a history of sensitivity to multiple allergens and enquiry of such history should be made before the treatment is started. Treatment should be continued for at least 10 days in cases of streptococcal infections and to confirm eradication of the organism, post-therapy cultures should be performed. Precautions: It should be used with caution in patients with known history of allergy. It is not recommended for chronic, severe, or deep-seated infections such as subacute bacterial endocarditis, meningitis, or syphillis. It should not be used as adjunctive prophylactic therapy prior to genito- urinary instrumentation or surgery, childbirth, etc. Side-effects: It is usually well tolerated but may occasionally cause transient nausea and diarrhea. Hypersensitivity reactions may include skin rashes, chills, fever, oedema, arthralgia, laryngeal oedema and anaphylaxis. The only reactions frequently observed may be fever and eosinophilia.

Pharmaceutical precautions

PEN-V syrup should be freshly prepared, stored in a cool place, preferably in a refrigerator. Reconstituted syrup should be used within 5 days if kept at room temperature or within 7 days if kept in a refrigerator. Containers should be tightly closed. Storage: PEN-V tablets and syrup should be stored in a cool dry place.

Package quantities

PEN-V Tablets: Cartons of 100 tablets in strip. PEN-V Syrup: Bottles containing powder to produce 50 ml of syrup when reconstituted.

Ref: FISONS (BANGLADESH) LIMITED

Cloxacillin sodium BP

FICLOX

Presentation

FICLOX 500 mg Capsules: Yellow and black capsules imprinted with company logo and ‘FICLOX 500 mg’; each capsule contains cloxacillin sodium BP equivalent to 500 mg cloxacillin. FICLOX Syrup: Bottles containing powder for preparation of 100 ml of yellow coloured, orange flavoured syrup; when reconstituted each 5 ml contains cloxacillin sodium BP equivalent to 125 mg cloxacillin. FICLOX Paediatric Drops: Bottles containing powder for preparation of 15 ml of yellow coloured, orange flavoured drops; when reconstituted each 1.25 ml contains cloxacillin sodium BP equivalent to 125 mg cloxacillin. A dropper to measure the 1.25 ml dose is provided. FICLOX 250 mg Injection: Powder in vials containing cloxacillin sodium BP equivalent to 250 mg cloxacillin. FICLOX 500 mg Injection: Powder in vials containing cloxacillin sodium BP equivalent to 500 mg cloxacillin.

Uses

FICLOX is indicated for the treatment of infections due to staphylococci resistant to benzylpenicillin; it is also used for mixed streptococcal and staphylococcal infections when the staphylococci are penicillin resistant. The following are typical indications: skin and soft tissue infections: Boils; Abscesses; Carbuncles: Furunculosis; Cellulitis; Infected Wounds; infected burns; Protection for skin grafts; Otitis media and externa; Infected skin conditions; e.g., ulcer, eczema and acne. Respiratory tract infections: Pneumonia; Lung Abscess; Empyema; Sinusitis; Pharyngitis; Tonsillitis; Quinsy. other infections caused by FICLOx sensitive organisms: Osteomyelitis; Enteritis; Endocarditis; Urinary tract infections; and Septicaemia.

Dosage and administration

Usual adult dosage: Oral: 500 mg four times daily. Intramuscular: 250 mg four to six hourly. Intravenous: 500 mg four to six hourly. Systemic dosages may be doubled where Necessary; oral doses should be administered half to one hour before meals. Intrapleural: 500 mg once daily. Intra articular: 500 mg once daily. Usual children’s dosage: 2 to 10 years: ½ adult dose. Under 2 years: ¼ adult dose. Administration: Intramuscular: 250 mg dissolved in 1.5 ml or 500 mg in 2 ml Water for Injection BP. Intravenous: 500 mg dissolved in 5 ml Water for Injection BP. The 5 ml solution is administered by slow intravenous injection (three to four minutes). FICLOX Injection may also be added to infusion fluids or injected, suitably diluted, into the drip tube over a period of three to four minutes. Intrapleural: 500 mg dissolved in 5 to 10 ml Water for Injection BP. Intra articular: 500 mg dissolved in up to 5ml Water for Injection BP or 0.5% lignocaine hydrochloride solution.

Contra-indications, warnings, etc

Contra-indications: Contra-indicated in patients with penicillin hypersensitivity. Precautions: Cloxacillin should be given with caution to patients with known histories of allergy. It should not be given by subconjunctival injection, or used in eye drops. Side-effects: Side-effects are those encountered with other penicillins and are usually of a mild transitory nature; they may include fever, diarrhea, indigestion, or rash, either urticarial or erythematous. In cases of rash of either type, treatment should be Discontinued.

Pharmaceutical precautions

FICLOX Syrup and Drops should be freshly prepared, stored in a cool place preferably in a refrigerator. Reconstituted syrup and drops should be used within 5 days if kept at room temperature, or within 7 days if kept in a refrigerator. Solutions for iM and direct IV injection should normally be used within 30 minutes of preparation. However, aqueous solution of FICLOX retain their activity for up to 24 hours at room temperature (25°C). FICLOX may be added to most intravenous fluids but should not be mixed with blood products or other proteinaceous fluids (e.g., protein hydrolysates). Storage: All the dosage forms of FICLOX should be stored in airtight containers and kept in a cool dry place. FICLOX injection vials should be stored at a temperature not exceeding 25° C.

Package quantities

FICLOX 500 mg Capsules: Cartons of 100 capsules in strip. FICLOX Syrup: Bottles containing powder to produce 100 ml of syrup when reconstituted. FICLOX Paediatric Drops: Bottles containing powder to produce 15 ml of drops when reconstituted. FICLOX 250 mg Injection: Cartons of 10 combipacks. Each combipack contains 1 vial of 250 mg and 1 ampoule of 5 ml Water for Injection BP for dilution. FICLOX 500 mg Injection: Cartons of 10 combipacks. Each combipack contains 1 vial of 500 mg and 1 ampoule of 5 ml Water for Injection BP for dilution.

Ref: FISONS (BANGLADESH) LIMITED

Ampicillin Trihydrate BP

FICILLIN

Presentation

FICILLIN Capsules: Scarlet and black capsules imprinted with company logo and ‘FICILLIN 250 mg’; each capsule contains ampicillin trihydrate BP equivalent to 250 mg ampicillin. FICILLIN Syrup: Bottles containing powder for preparation of 100 ml of creamy white, raspberry flavoured syrup; when reconstituted each 5 ml contains ampicillin trihydrate BP equivalent to 125 mg ampicillin. FICILLIN Paediatric Drops: Bottles containing powder for preparation of 15 ml of creamy white raspberry flavoured drops; when reconstituted each 1.25 ml contains ampicillin trihydrate BP equivalent to 125 mg ampicillin. A dropper to measure the 1.25 ml dose is provided.FICILLIN 250 mg Injection: Powder in vials containing ampicillin sodium BP equivalent to 250 mg ampicillin.FICILLIN 500 mg Injection: Powder in vials containing ampicillin sodium BP equivalent to 500 mg ampicillin.

Uses

FICILLIN is a broad spectrum semi-synthetic antibiotic indicated for the treatment of infections due to susceptible Gram positive organisms including streptococci, penicillin sensifive taphylocooci and enterococci and susceptible strains of Gram- negative bacteria including Haemophilus influenza, Esoherichia coli, Proteus mirabilis, Neisseria gonomhoeae, N Meningitidis, Shigellae, Salmonella typhi and other Salmonellae Typical indications include: Ear, nose and throatInfections; Bronchitis; Pneumonia; Urinary tract Infections; Gonorrhoea, Obstetric and gynaecological infections; Septicaemia; Peritonitis; Meningitis; Enteric fever; Gastro-intestinal infections; and Biliary tract infections.

Dosage and administration

Usual adult dosage (oral except where stated): Ear, nose and throat infections: 250 mg four times daily. Bronchitis: Routine therapy: 250 to 500 mg four times daily. High dosage therapy: 1 g four times daily. Pneumonia: 500 mg four times daily. Urinary tract infections: 500 to 750 mg three times daily. Gonorrhoea: 3.5 g orally with 1 g probenecid as a single dose. Repeated doses are recommended for the treatment of females. Gastro-intestinal infections: 500 to 750 mg three to four times daily. Enteric fever: Acute: 1 to 2 g four times daily for two weeks. Carrier: 1 to 2 g four times daily for four to twelve weeks Septicaemia, endocarditis, osteomyelitis: 500 mg four to six times daily lM or IV for one to six weeks. Peritonitis, intra-abdominal sepsis: 500 mg four times daily IM or IV. Meningitis: Adult dosage: 2 g six hourly IV for two days; 500 mg to 1 g six hourly lM from third day onwards. Children’s dosage for meningitis :150 mg/kg body weight daily iv for two days in divided doses;100 mg/kg body weight daily in divided doses from third day onwards. Usual children’s dosage (oral except where stated): 2 to 10 years: 112 adult dose. Under 2 years: ¼ adult dose. in severe infections dosages may be increased, or FICILLIN be given by injection. oral doses of FicILLIN should be taken half to one hour before or three hours after a meal. Administration: intramuscular: 250 mg or 500 mg dissolved in 1.5 ml Water for Injection BP. Ntravenous: 250 mg or 500 mg dissolved in 5-10 ml Water for injection BP given by slow injection( three to four minutes). FICILLIN may also be added to infusion fluids or injected, suitably diluted, into the drip tube over a period of three to four minutes. Intraperitoneal: At least 500 mg per 5-10 mlWater for Injection BP daily. Intrapleural:500 mg daily in 5-10 ml Water for injection BP. Intra articular: 500 mg daily, dissolved in up to 5 ml Water for Injection BP or 0.5% procaine hydrochloride solution. Local use in surgery: 1 g sterile powder sprinkled into the wound extra-peritoneally or into muscle layers to prevent wound infection post-operatively.

Contra-indications, warnings, etc.

Contra-indications: Contra-indicated in patients known to be hypersensitive to penicillin and it should be used with caution in patients with known histories of allergy. It should preferably not be used in patients with infectious mononucleosis. Precautions: In renal impairment the excretion of antibiotic will be delayed and depending on the degree of mpairment it may be necessary to reduce the total daily dosage. Side-effects: Side-effects are rare and usually of a mild, transitory nature. Skin rashes, either urticarial or erythematous have been observed; the urticarial reactions are typical of penicillin hypersensitivity while the erythematous rashes are specific to ampicillin. Most patients with infectious mononucleosis develop a skin rash. It is advisable to discontinue treatment when a rash is reported. Diarrhoea, nausea, and vomiting have occasionally Occurred.

Pharmaceutical precautions

FICILLIN Syrup and Drops should be freshly prepared, stored in a cool place, preferably in a refrigerator. Reconstituted syrup and drops should be used within 5 days if kept at room temperature, or within 7 days if kept in a refrigerator. FlClLLIN solution for injection should be used immediately after preparation. FICILLIN may be added to most intravenous fluids but should not be mixed with blood products or other proteinaceous fluids (e.g., protein hydrolysates). In intravenous solutions containing dextrose or other carbohydrates, FICILLIN injection should be infused within one hour of preparation. Storage: All the dosage forms of FICILLIN should be stored in airtight containers and kept in a cool dry place. FICILLIN injection vials should be stored at a temperature not exceeding 25°C.

Package quantities

FICILLIN Capsules: Cartons of 100 capsules in strip. FICILLIN Syrup: Bottles containing powder to produce 100 ml of syrup when reconstituted. FICILLIN Paediatric Drops: Bottles containing powder to produce 15 ml of drops when reconstituted. FICILLIN 250 mg Injection: Cartons of 10 combipacks. Each combipack contains 1 vial of 250 mg and 1 ampoule of 5 ml Water for Injection BP for dilution. FICILLIN 500 mg Injection: Cartons of 10 combipacks. Each comipack contains 1 vial of 500 mg and 1 ampoule of 5 ml Water for Injection BP for dilution.

Ref: FISONS (BANGLADESH) LIMITED

Amoxycillin Trihydrate BP

FIMOXYL

Presentation

FIMOXYL Capsules: Orange and black capsules imprinted with company logo and ‘FlMOXYL 250 mg’; each capsule contains amoxycillin trihydrate BP equivalent to 250 mg amoxycillin. FIMOXYL Syrup: Bottles containing powder for preparation of 100 ml of yellow coloured, banana flavoured syrup; when reconstituted each 5 ml contains amoxycillin trihydrate BP equivalent to 125 mg amoxycillin. FIMOXYL Paediatric Drops: Bottles containing powder for preparation of 15 ml of yellow coloured banana flavoured drops; when reconstituted each 1.25 ml contains amoxycillin trihydrate BP equivalent to 125 mg amoxicillin. A dropper to measure the 1.25 ml dose is provided. FIMOXYL 250 mg Injection: Powder in vials containing amoxycillin sodium BP equivalent to 250 mg amoxicillin. FIMOXYL 500 mg injection: Powder in vials containing amoxycillin sodium BP equivalent to 500 mg amoxycillin.

Uses

FlMOXYL is a broad spectrum antibiotic used to treat a wide range of infections caused by susceptible Gram-positive and Gram-negative organisms. It is indicated for the treatment of the following bacterial infections: Respiratory tract, ENT infections: Acute and chronic bronchitis, pneumonia, otitis media, sinusitis, tonsillitis, pharyngitis, and laryngitis. Urinary tract infections: Pyelonephritis, cystitis, and Urethritis. Obstetric and gynaecological infections: Bacteriuria in pregnancy, septic abortion, intra-abdominal sepsis. and puerperal sepsis Gastro intestinal infections: Typhoid and paratyphoid. Skin and soft tissue infections: Cellulitis, infected wounds and abscesses. Generalised infections: Septicaemia, bacterial endocarditis, meningitis, peritonitis and osteomyelitis. Venereal infections: Gonorrhoea and syphilis FIMOXYL may also be used as prophylactic cover for patients at risk of developing endocarditis when undergoing surgery.

Dosage and administration

Usual adult dosage:

Oral: 250 mg three times daily increasing to 500 mg three times daily for more severe infections. Injectables: 250- 500 mg lM every 8 hourly (or more frequently, if found necessary by the physician) for moderate infections. 500 mg-1g IV every 6 hourly for severe infections.Usual children’s dosage Oral 2 to 10 years: Half of the adult dose. Under two years: 1/4th of the adult dose. lnjectables (upto 10 years): 50-100 mg/kg body weight IM or IV (depending on the severity) in three to four equal divided doses. Specific dosage recommendation: Typhoid and Paratyphoid Adult: 4 g daily in divided doses for 14-21 days. Children: 100 mg/ kg/ day in divided doses for 14-21 days. Typhoid Carrier States: 3 to 4 g in divided doses for a minimum of one month. Syphilis: 250 mg every 6 hours for 1 month to 5 months according to the stage of the disease and serological response. Simple Acute Urinary Tract Infection: Short course therapy: Two 3 g doses with 10-12 hours between the doses. Meningitis: Adults: 150 mg/kg/day IV in equally divided doses. Children: 100-150 mg/kg/day IV in equally divided doses. Gonorrhoea: A single 3 g dose. Dental abscess (as an adjunct to surgical management): Two 3 g doses with 8 hours between the doses. Severe or recurrent acute otitis media: 3 to 10 years: 750 mg twice a day for two days may be used as an alternative course of treatment. Prophylaxis of Endocarditis: Adults: 3 g orally 1 hour before and 6 hours after procedure or 1 g IM with induction of anaesthesia and 500 mg orally 6 hours later. Children: Half the adult dose. Patients with prosthetic heart valves or with a history of endocarditis will require gentamicin in addition. Administration: Oral: Using capsule, syrup or paediatric drops. Intramuscular: 250 mg: Add 1.5 ml Water for Injection BP and shake vigorously. 500 mg: Add 2.5 ml Water for Injection BP and shake vigorously. If pain is experienced on intramuscular injection, a sterile 1% solution of lignocaine hydrochloride or 0.5% solution of procaine hydrochloride may be used in place of Water for Injection. Intravenous: 250 mg: Dissolve in 5 ml Water for Injection BP. 500 mg: Dissolve in 5-10 ml Water for Injection BP FIMOXYL Injection, suitably diluted, may be injected directly into a vein or drip tube, taking 3 to 4 minutes. Intravenous Infusion: Solutions may be prepared as described for intravenous injections and then added to an intravenous solution and administered over a period of 30 to 60 minutes.

Note: A transient pink colouration or slight opalescence may appear during reconstitution.Reconstituted solutions are normally a pale straw Colour.

Contra-indications, warnings, etc.

Contra- indications: Amoxycillin is contra-indicated in penicillin hypersensitive patients. It should not be given to patients with infectious mononucleosis (glandular fever). Precautions: In renal impairment the excretion of the antibiotic will be delayed and depending on the degree of impairment it may be necessary to reduce the total daily dosage. Side-effects: Side-effects are usually of a mild transitory nature, they may include diarrhoea, indigestion, or occasionally rash, either urticarial or erythematous. In either cases of rash, the treatment should be Discontinued.

Pharmaceutical precautions

FIMOXYL Syrup and Drops should be freshly prepared, stored in a cool dry place, preferably in a refrigerator. Reconstituted syrup and drops should be used within 5 days if kept at room temperature, or within 7 days if kept in a refrigerator. FIMOXYL solution for injection should be used immediately after preparation. FiMOXYL may be added to most intravenous fluids but should not be mixed with blood products or other proteinaceous fluids (e.g., protein hydrolysates). In intravenous solutions containing dextrose or other carbohydrates, FlMOXYL injection should be infused within one hour of preparation. Storage: All the dosage forms of FlMOXYL should be kept in a cool dry place. FIMOXYL injection vials should be stored at a temperature not exceeding 25°C.

Package quantities

FIMOXYL Capsules: Cartons of 100 capsules in strip. FIMoxYL syrup: Bottles containing powder to produce 100 ml of syrup when reconstituted. FIMoxYL Paediatric Drops: Bottles containing powder to produce 15 ml of drops when reconstituted. FIMOXYL 250 mg injection: Cartons of 10 combipacks. Each combipack contains 1 vial of 250 mg and 1 ampoule of 5 ml Water for Injection BP for dilution. FIMOXYL 500 mg Injection: Cartons of 10 combipacks. Each combipack contains 1 vial of 500 mg and 1 ampoule of 5 ml Water for Injection BP for dilution.

Ref: FISONS (BANGLADESH) LIMITED