Envit-M Multivitamin with Mineral

Description
Envit® -M is a balanced preparation of Vitamins and Minerals. All are in appropriate amounts, essential to replenish vitamin and mineral deficiencies and thus maintain proper growth and resistance of body against different diseases. Iron, Copper, Calcium, Manganese, Zinc that present in Envit® -M tablet act as co-factors for cell enzymes and thus help in normal metabolic functions.

Composition
Each Envit® -M tablet contains:

Vitamin A	BP	1.50 mg
Vitamin D	BP	10.00 mg
Vitamin C	BP/USP	64.00 mg
Vitamin E	BP	15.00 IU
Thiamine Mononitrate (Vit-B1)	BP	1.50 mg
Riboflavin (Vit. B2)	BP	1.70 mg
Nicotinamide	BP	20.00 mg
Pyridoxine Hydrochloride (Vit- B6)	BP	2.00 mg
Cyanocobalamin (Vit. B12)	BP	6.00 mg
Folic acid	BP	0.40 mg
Calcium Pantothenate	USP	10.92 mg
Ferrous Sulphate	BP	50.00 mg
Potassium Iodide	USP	196.00 mg
Potassium Sulphate	BP	11.14 mg
Magnesium Sulphate	BP	1.00 mg
Cupric Sulphate	BP	2.00 mg
Zinc Sulphate	BP	37.04 mg

Indication
Envit® -M is indicated for the treatment and/or prevention of Vitamin and Mineral deficiencies. Such as:

Conditions where absorption of Vitamins and Minerals become decreased, such as: Inadequate food intake due to restriction or imbalanced diet, which is always related to malnutrition and loss of appetite; gastric and intestinal dysfunction; long term alcoholism; chronic and acute infection; congestive heart failure; hyperthyroidism etc. are also the causes of inadequate absorption of vitamins.

Destruction of intestinal flora due to contraceptive pills, antibiotics and other drugs.

Special conditions relating deficiency of B Vitamins, Vitamin-C, A, D and minerals.

Conditions where requirement of Vitamin increases such as : Post operative condition, severe injury or burn, tissue destruction and wound, pregnancy, lactation, excessive bleeding during menstruation, growing children and for old ages.

To increase body resistance.

Dosage and Administration
1-2 tablets daily or as directed by the Physician.

Precaution
During the 1st trimester of pregnancy, larger dosage of Vitamin-A may cause teratogenesis, so this should be considered during prescribing Multivitamin. Again, excessive doses of Vitamin-A and D can lead to hypervitaminosis. Iron and Zinc chelate with Tetracyclines and absorption of all three agents may be impaired.

Side effect
Multivitamin with Mineral preparation with ordinany doses are usually nontoxic.

Contraindication
It is contraindicated to the patients with known hypersensitivity to any of its constituents.

How supplied
Envit® -M Tablet : Bottle contains 30 film coated tablets.

Manufacturer’s Source: IBN SINA

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Doxysina - Doxycycline Capsule

Description:
Doxysina® is a semisynthetic oxytetracycline derivative with bacteriostatic activities. It acts principally by interference with protein synthesis. Doxysina® is a broad spectrum antibiotic and is active against a wide range of gram-positive and gram-negative bacteria, spirochetes, chlamydia, mycoplasma, rickettsiae etc.

The drug is almost completely absorbed (96%) from gastro-intestinal tract. Food does not interfere with the absorption of Doxycycline. 90% of the drug in circulation is bound to plasma protein. The drug is excreted in the faeces, largely as an inactive conjugate or perhaps as a chelate.

Composition:
Each Doxysina® Capsule contains Doxycycline HCl, equivalent to Doxycycline BP 100 mg.

Indication:
Doxysina® has been used in the treatment of a large number of infections caused by susceptible organisms.

Respiratory tract infection : Pneumonia, influenza, pharyngitis, tonsillitis, bronchitis, sinusitis, otitis media and other streptococcal and staphylococcal infections where tetracycline resistance is not a problem.
Genitourinary tract infection : Pyelonephritis, cystitis, urethritis, gonorrhea, epididymitis, syphilis, chancroid and granuloma inguinale.
Chlamydial infection : Lymphogranuloma venereum, psittacosis, trachoma.
Intestinal diseases : Whipples disease, tropical sprue, blind loop syndrome. In acute intestinal amoebiasis Doxysina® may be a useful adjunct to amoebicide.
Bacillary infection : Brucellosis, tularaemia, cholera, traveller's diarrhoea.
Acne: Acne vulgaris, acne conglobata and other forms of acne.
Other infections : Actinomycosis, yaws relapsing fever, leptospirosis, typhus, rickettsial pox and Q fever, cellulitis, furunculosis, abscess and infections
caused by Mycobacterium marinum, Bordetella pertussis and Bacillus anthracis. Also given for prophylaxis of malaria.

Dosage and administration:
Adult : 200 mg at a time or 100 mg every 12 hours for the first day followed by 100 mg per day. The dosage may be doubled depending on severity of the infection.
Children (Over 8 years of age) : Patients weighed 100 pounds or less (<45 kg)2 mg/lb (4.4 mg/kg) divided into two doses on the first day of treatment; follow with 1 mg/lb (2.2 mg/kg) given as a single daily dose or divided into two doses on subsequent days. More severe infections : Upto 2 mg/lb (4.4 mg/kg) may be used. For children over 100 pounds (>45 kg) use the usual adult dose. 
Doxycycline may be taken anytime of the day and in case of gastric irritation, may be taken with food or milk.
Special Dosage Schedule : Acute gonococcal infection : 200 mg immediately, then 100 mg at bed time on the first day, followed by 100 mg 2 times/day for 3 days.
Primary and secondary syphilis : 300 mg per day in divided doses for at least 10 days. Uncomplicated urethral, endocervical or rectal infections in adult caused by Chlamydia trachomatis : 100 mg twice daily for at least 7 days.
Acne : 50 mg daily for 6-12 weeks or longer.
Travelers' Diarrhoea : Doxycycline is used to prevent Traveler's diarrhoea caused by enterotoxigenic E. coli in a dose of 100 mg once a day for 3 weeks.

Precaution:
The use of drug of tetracycline group during tooth development (last half of pregnancy, infancy and childhood to the age of 12 years) may cause permanent discolouration of the teeth. Tetracyclines, therefore, should not be used in these age groups unless other drugs are not likely to be effective or are contraindicated.

Side effect:
Doxycycline may produce gastrointestinal irritation to a varying degree in some but not all individuals. Epigastric distress, abdominal discomfort, may occur. Long term therapy with doxycycline may produce hematological changes. Various skin reactions including rashes, urticaria, exfoliative dermatitis may follow the use of Doxycycline but they are rare.

Contraindication:
Hypersensitivity to any of the tetracyclines contraindicate the use of Doxycycline.

How supplied:
Doxysina® Capsule : Box contains 10x10's capsules in blister strip.

Manufacturer’s Source: IBN SINA

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Dopadon® Domperidone-Gastrokinetics

Description:
Dopadon®blocks the receptor binding activity of Dopamine. Though all of the Dopaminergic receptors (D1, D2, D3, D4& D5) are present in the brain but Dopadon®blocks only the chemoreceptor trigger zone and stomach. Dopadon®has an action to the gastrointestinal motility. Dopadon®does not readily enters the brain that’s the reason Dopadon®has insignificant effects (psychotropic and neurologic) on the dopaminergic receptors of Brain. Dopadon®accelerates transit through the small intestine, facilitates gastric emptying, enhances antral and duodenal peristalsis and regulates contraction of the pylorus. Dopadon®increases lower esophageal spinchter pressure and esophageal peristalsis and prevents the regurgitation of gastric content, thus prevents the rumination.

Composition:

Dopadon®Tablet : Each Tablet contains Domperidone BP (as Domperidone Maleate BP) 10 mg.

Dopadon®Suspension : Each 5 ml suspension contains Domperidone BP 5 mg.

Indication:
1) Stimulation of Gastrointestinal mobility
a Esophageal reflux, Reflux esophagitis and gastritis
b. Diabetic gastroparesis.
c. Heartburn with or without regurgitations of gastric contents in the mouth.
d. Non-ulcer dyspepsia
e. Functional dyspepsia
f. Speeding barium transit in “follow-through” radiological studies.
g. Acute nausea and vomiting.

2) Prevention and Symptomatic relief of acute nausea and vomiting in adults from any cause but specifically:
a. Cytotoxic therapy
b. Nausea and Vomiting associated with L-dopa and bromocriptine treatment for parkinsonian patients.
c. Radiological therapy.

3) In treatment of migraine with paracetamol

Dosage and administration:
Adults : 1-2 Dopadon®Tablet (10 to 20 mg) or 10-20 ml Dopadon®Suspension every 4-8 hours daily.
Children : 0.2 - 0.4 ml Dopadon®Suspension/10 kg or 0.2 - 0.4 ml/Dopadon® Suspension per kg body weight every 4 - 8 hours daily.
Dopadon®Should be taken 15-30 minutes before meals.

Side effect:
Hyperprolactinemia may produce during the treatment with domperidone, which may result in galactorrhea, breast enlargement, soreness and reduced libido. Dry mouth, thirst, headache, nervousness, drowsiness, diarrhoea, skin rash and itching may occur. Extrapyramidal reactions are seen in patients in clinical studies.

Precaution:
Domperidone is highly metabolized in liver, it should be used with caution in patient with hepatic impairement. There may be increased risk of extrapyramidal reactions in young children because of incompletely developed blood brain barrier.

Contraindication:
Domperidone is contraindicated to patients having known hypersensitivity to this drug and in case of neonates. Domperidone should not be used whenever gastro-intestinal stimulation might be dangerous i.e; gastrointestinal hemorrhage, mechanical obstruction or perforation. Also contraindicated in patients with prolactin releasing pituitary tumor (prolactinoma).

Use in pregnancy and lactation:
Pregnant Woman : Domperidone is not recomended in pregnancy. Lactating mother : Domperidone may precipitate galactorrhea and improve post-natal lactation. It is secreted in breast milk but in very small quantitiesinsufficient to be considered harmful.

Drug interaction:
Domperidone may reduce the hypoprolactinemic effect of bromocriptine. The action of domperidone on GI function may be antagonized by anti-muscarinics and opoid analgesics. Domperidone and MAO (monoamine oxidase) inhibitors combination treatment should be taken carefully.

How supplied:
Dopadon®Tablet : 10 x 10’s tablets in blister pack in a printed carton. 
Dopadon®Suspension : Each bottle contains 60 ml suspension.

Manufacturer’s Source: IBN SINA

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Dofixim® - Cefpodoxime proxetil USP - Antibacterial

Description:
Cefpodoxime proxetil is an orally administered prodrug that is de-esterified in the intestinal wall to release cefpodoxime a broad spectrum, semisynthetic 3rd generation cephalosporin antibiotic. Like other -lactam antibiotics it is bactericidal and acts by inhibiting cell wall synthesis. It is more active than other oral cephalosporin against respiratory bacterial pathogens.

Composition:
Dofixim®Capsule : Each capsule contains Cefpodoxime proxetil USP equivalent to 100 mg Cefpodoxime.
Dofixim®Tablet : Each Tablet contains Cefpodoxime proxetil USP equivalent to 200 mg Cefpodoxime.
Dfixim®Dry Suspension : Each 5 ml reconstituted suspension contains Cefpodoxime proxetil USP equivalent to 40 mg Cefpodoxime.

Indication:

Upper respiratory tract infection : Acute otitis media, Acute maxillary sinusitis, Pharyngitis, Tonsilitis.
Lower respiratory tract infection : Acute community acquired pneumonia, acute bacterial exacerbation of chronic bronchitis.
Uncomplicated urinary tract infection : Cystitis, Pyuria. Skin and soft tissue infection : Furuncle, Cellulitis, Subcutaneous abscess, infectious atheroma.
Sexually transmitted disease : Acute uncomplicated urethral and cervical gonorrhoea.
Gastrointestinal Tract Infection : Typhoid fever

Drug interaction:

Antacids : Concomitant administration of high doses of antacids or H2- Blocker reduces peak plasma level by 24% to 42% and the extent of absorption by 27% to 30% respectively.

Probenecid : It inhibits the excretion of Cefpodoxime.
Nephrotoxic drugs : Close monitoring of renal function is advised when Cefpodoxime is administered concomitantly with compounds of known nephrotoxic potential.

Dosage and administration:
Dofixim®capsule should be administered only with food to enhance absorption but suspension may be given without regard to food.

Adults (Age 13 years and older)

Types of infection	Dosage	Duration
Upper respiratory tract infection including tonsillitis and pharyngitis.	100 mg	12 hourly for 5-10 days
Acute exacerbation of chronic bronchitis	200 mg	12 hourly for 10 days
Acute community acquired pneumonia	200 mg	12 hourly for 14 days
Uncomplicated gonorrhoea	200 mg	Single dose
Uncomplicated urinary tract infection	100 mg	12 hourly for 7 days
Skin and soft tissue infection	200-400 mg	12 hourly for 7-14 days
Acute maxillary sinusitis	200 mg	12 hourly for 10 days

Children (Age 15 days to 9 years)

Age of children	Dosage	Duration
15 days-6 months 6 months-2 years 3 years-8 years Over 9 years	4 mg/kg every 40 mg every 80 mg every 100 mg every	12 hours 12 hours 12 hours 12 hours

Side effects:
Dofixim®has very few side effects. Diarrhoea and rarely antibiotic associated with colitis, nausea, vomiting, abdominal discomfort etc. may occur. Other side effects include rashes, pruritus, urticaria, serum sickness, chest pain, myalgia, dyspepsia, dizziness, vertigo, fungal and vaginal infection.

Use in pregnancy and lactation:
There is no well-controlled and sufficient study of Cefpodoxime proxetil regarding its use in pregnancy. It was neither teratogenic nor embryocidal in animal trial. This drug should be given during pregnancy only if clearly needed. Because Cefpodoxime is excreted in human milk, a decision should be made whether to discontinue brest feeding or to discontinue the drug.

Contraindication:
Dofixim®is contraindicated in patient with known hypersensitivity to it or to other cephalosporin antibiotics.

How supplied:
Dofixim® Capsule : Box contains 2 X 4’s capsules in Alu-Alu Blister pack.
Dofixim® Tablet : Box contains 3 X 4’s capsules in Alu-Alu Blister pack.
Dofixim® Dry Suspension: Bottle contains dry powder for 50 ml & 100 ml suspension.

 Manufacturer’s Source: IBN SINA

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Diplor® Amlodipine besylate BP Film Coated Tablet

Description:
Diplor® (Amlodipine) is a dihydropyridine calcium channel blocker, with a longer duration of action, used for the treatment of hypertension and angina pectoris. Administration of Diplor® (Amlodipine) results primarily in vasodilation, with reduced peripheral resistance, blood pressure and afterload, increased coronary blood flow and a reflex increase in heart rate. This in turn results in an increase in myocardial oxygen supply and cardiac output.

Composition:
Diplor® Tablet : Each tablet contains Amlodipine besylate BP equivalent to 5 mg Amlodipine.
Diplor®-10 Tablet : Each tablet contains Amlodipine besylate BP equivalent to 10 mg Amlodipine.

Indication:
1) Hypertension
2) Chronic stable angina
3) Vasospastic angina (Prinzmetal's or Variant angina)

Dosage and administration:

Hypertension : Usual dose is 5 mg once daily & maximum dose is 10 mg daily. Small, fragile elderly individuals, or patients with hepatic insufficiency may be started on 2.5 mg once daily. In the treatment of hypertension it may be used alone or in combination with other antihypertensive agents.

Angina Pectoris & Vasospastic Angina :The recommended dose is 5-10 mg daily, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Most patient will require 10 mg for adequate effect. Amlodipine may be used alone or in combination with other anti-anginal drugs.

Co-administration with other Antihypertensive or Antianginal drugs:Amlodipine has been safely administered with thiazides, ACE inhibitors, Beta Blockers, Long acting Nitrate or Sublingual Nitroglycerin.

Acute Over Dosage:
In humans, experience with over dosage of Amlodipine is limited. If massive over dosage occurs, active cardiac and respiratory monitoring should be instituted. Frequent blood pressure measurements are essential.

Side effect:
The most common side effects are dizziness, flushing, headache, hypotension and peripheral oedema, gastrointestinal disturbance, increased the frequency of micturation, lethargy and eye pain may occur. A paradoxical increase in ischemic chest pain may occur at the start of the treatment.

Caution:
Caution should be taken in patients with hepatic impairment, congestive heart failure, sinus node disease, aortic stenosis, beta-blocker withdrawal, during pregnancy and breast-feeding.

Contraindication:
Amlodipine is contra-indicated in patients with known hypersensitivity to dihydropyridine derivatives.

Storage Instruction:
Store the tablets in a dry place, at 15° - 30°C, away from light. Keep all the medicines away from the reach of children.

How supplied:
Diplor® Tablet : Each box contains 3 x 10's Tablets in Blister Pack.
Diplor®-10 Tablet : Each box contains 3 x 10's Tablets in Blister Pack.

Manufacturer’s Source: IBN SINA

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Darmacort® Clobetasol Propionate USP 0.05% w/w Cream/Ointment

Description:
Clobetasol Propionate is a corticosteroid used typically for it's glucocorticoid activity in the treatment of various skin dieseases. It has potent anti-inflammatory and immunosuppressive effects.

Composition:
Dermacort®Cream/Ointment : White nonstaining water miscible cream
/Ointment containg Clobetasol Propionate USP 0.05% w/w.

Indication:
Dermacort®Cream/Ointment is indicated in:
* Initial control of all forms of hyperacute eczema.
* Chronic hyperkeratotic psoriasis of any of the body.
* Chronic hyperkeratotic eczema of the hands and feet.
* Hypertrophic lichen planus.
* Severe acute photosensitivity.
* Pretibial myxoderma.
* Suppression of reaction after cryotherapy.

Dose & Administration
Apply Dermacort® Cream/Ointment sparingly to the affected areas once or twice daily until improvement occurs. As with other highly active topical steroid preparation, therapy should be discontinued when control is achieved. If a longer course is necessary, it is recommended that treatment should not be continued for more than four weeks without the patient's condition being observed. Repeated short courses of Dermacort®may be used to control exacerbation. In very resistant lesions especially where there is hyperkeratosis, the anti-inflammatory effect of Dermacort®can be enhanced by occluding the treatment area with polythene film. Only overnight occlusion is usually abequate to bring about a satisfactory response, Thereafter, improvement can usually be maintained by application without occlusion.

Contraindication:
It is contraindicated in:
* Cutaneous infections such as impetigo, tinea corporis and herpes simplex.
* Infestation such as scabies.
* Neonates (children less than one year old.)
* Acne vulgaris.* Rosacea
* Gravitational ulceration

Precaution: 

Long-term continuous use of Clobetasol cream/ointment should be avoided, particularly in infants and children, in whom adrenal suppression occurs readily.
If required for use in children, it is recommended that the treatment should be reviewed weekly. The face more than other area of the body may exhibit atrophic changes after prolonged treatment with potent topical corticosteroids. This must be borne in mind when treating facial conditions. If applied to the eyelid, care is needed to ensure that the preparation doesn't enter the eye, as glaucoma may result. Appropriate microbial therapy should be used whenever treating inflammatory lesions, which have been infected. Any spread of infections require withdrawal of corticosteroid therapy and institution of suitable systemic chemotherapy.
Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressings, and the skin should be cleansed before a fresh dressing is applied.

Use in pregnancy & lactation:
Topical administration of corticosteroids to the pregnant animals can cause abnormalities of fetal development. The relevance of this finding to human being has not been established. However, topical steroids shouldn't be used extensively in pregnancy, i.e. in large amount or for prolonged period.

Side-effect:
Provided the weekly dosage is less than 50 gm in adult, any pituitary adrenal suppression is likely to be transient with a rapid return to normal values, once the short course of steroid therapy has ceased. Prolonged and intensive treatment with a highly active corticosteroid preparation may cause atrophic changes, such as thinning, striae and dilatation of the superficial blood vessels, particularly when occlusive dressings are used or where skin folds are involved. Clobetasol cream/ointment is usually well tolerated but if signs of hypersensitivity appear, application should be stopped immediately.

How supplied:
Dermacort®Cream/Ointment : Tube contains 10 gm cream/ointment.

Manufacturer’s Source: IBN SINA

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Cefixim Cefixime-Antibiotic

Description:
Cefixim®is a broad spectrum, third generation oral Cephalosporin antibiotic for oral use. It is a bactericidal and is stable to hydrolysis by beta-lactamases. The drug kills bacteria by interfering with the synthesis of bacterial cell wall. It is highly effective against most Enterobacteriaceae, Haemophilus influenzae, Neisseria gonorrhoeae, -haemolytic Streptococcus and Streptococcus pneumoniae. 
About 65% of the drug in thecirculation is bound to plasma protein. Cefixim® is mainly excreted unchanged in bile and urine.

Composition:
Cefixim®Capsule : Each capsule contains Cefixime trihydrate USP, equivalent to Cefixime USP 200 mg.
Cefixim®Dry Suspension : Each 5 ml suspension (reconstituted from Dry Syrup) contains Cefixime trihydrate USP, equivalent to Cefixime USP 100 mg.

Indication:
Cefixim®is indicated in the treatment of following acute infections caused by susceptible microorganisms:
Upper respiratory tract infection (URTI) : Otitis media and others where causative organisms are known or suspected to be resistant to other commonly used antibiotics or where treatment failure may carry significant risk.
Lower respiratory tract infection (LRTI) : Bronchitis.
Gastrointestinal tract infection (GITI) : Typhoid fever.
Urinary tract infection (UTI): Cystitis, cystourethritis, pyelonephritis.

Dosage and administration : 

With Cefixim®the usual course of treatment is 7 days. This may be continued up to 14 days. 
Adults & Children over 10 years old: The recommended adult dosage is 1-2 capsule (200-400 mg) daily according to the severity of infection, given in either as a single dose or in two divided doses. 
Elderly: Elderly patients may be given the same dose as recommended for the adults. Renal functions should be assessed and dosage should be adjusted in severe renal impairment.
Children : The recommended dosage for children is 8 mg/kg/day administered as single dose or in two divided dose. 

As a general guide the following daily doses are suggested:
Cefixim®
Children (6-12 months) : Suspension 3.75 ml (75 mg) daily.
Children (1-4 years) : Suspension 5 ml (100 mg) daily.
Children (5-10 years) : Suspension 10 ml (200 mg) daily.
Children weighing more than 50 kg or older than 10 years : Adult dose of Cefixim®(200-400 mg daily) is recommended.

Pecaution:
In presence of impaired renal function Cefixim®should be administered with caution. In patient creatinine clearance less than 20 ml/min, it is recommended that a dose of 200 mg once daily should not be exceeded.

Use in Pregnancy and Lactation:
Cefixim®should not be used in pregnancy or nursing mother unless considered essential by the physician.

Side effect:
Cefixim®is generally well tolerated. The majority of adverse reactions observed are mild and self-limiting in nature. GIT disturbances : Diarrhoea and changes in stool colour, nausea, abdominal pain, dyspepsia, vomiting and flatulence. CNS disturbances: Headache and dizziness. Hypersensitivity reactions: Rash, pruritus, urticaria, drug fever and arthralgia have been observed.

Contraindication:
Cefixim®is contraindicated in patients with known hypersensitivity to Cephalosporin group of drugs.

How supplied:
Cefixim® Capsule : Box contains 1 x 5’s capsules in blister pack.
Cefixim® Dry Suspension : Bottle contains dry powder for 50 ml suspension.

Manufacturer’s Source: IBN SINA

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Bromotex - Bromhexine Hydrochloride

Description:
Bromotex® (Bromhexine HCl) is highly effective mucolytic expectorant. 

Composition: 
Bromotex® Syrup: Each 5 ml Syrup contains Bromohexine Hydrochloride BP 4 mg.

Indication:
Bromotex® (Bromhexine HCl) is indicated in the treatment of respiratory disorders associated with productive cough. These include; tracheobronchitis, bronchitic with emphysema, bronchiectasis, bronchitis with bronchospasm, chronic inflammatory pulmonary conditions and pneumoconiosis.

Dosage and administration: 
Bromotex® Syrup: 
Adults: The recommended daily dose is 2 to 4 teaspoonful 3 tines daily. Initially 4 teaspoonful 3 times daily and then as required. 
Children: Suggested dosage for children under 2 years is ¼ teaspoonful 3 times daily, for 2-5 years ½ teaspoonful 3 times daily and for children aged 5-10 years 1 teaspoonful 3 times daily.

Precaution: 
Mucolytics may disrupt the gastric mucosa so bromhexine should be used with care in patients with a history of peptic ulceration. Care is also advisable in asthmatic patients.

Contraindication:
Bromhexine is contraindicated for use in patients with known hypersensitivity to bromhexine hydrochloride (or any of the other ingredients in the product).

Side effect:
Gastrointestinal side effects may occur occasionally with Bromhexine and a transient rise in serum aminotransferase values has been reported. Other reported adverse effects include headache, dizziness, sweating and skin rash.

Use in pregnancy and lactation:
Category B: Bromhexine has been taken by a large number of pregnant women and women of child bearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.
It is not known whether Bromhexine is excreted in breast milk or whether it has a harmful effect on the breastfeeding infant. Therefore it is not recommended for breastfeeding mothers unless the potential benefits to the patient are weighed against the possible risk to the infant.

Storage:
Store at a cool and dry place. Protect from light.

How supplied:
Bromotex® Syrup: Each PET bottle contains 100 ml syrup and a plastic spoon.

Manufacturer’s Source: IBN SINA

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Bactin - Ciprofloxacin 0.3% - Sterile Eye Drops & Ointment

Description:
Bactin® Eye Drops is 0.3% isotonic sterile aqueous ophthalmic solution of Ciprofloxacin. Bactin® Eye Ointment is 0.3% ophthalmic sterile ointment of Ciprofloxacin. Ciprofloxacin is a broad spectrum fluoroquinolone antibacterial, having bacteriocidal activity against a wide range of Gram positive and Gram negative pathogenic bacteria. Ciprofloxacin achieves therapeutic level in various ocular tissues and fluids, hence topical administration of this drug is useful in the treatment of various ocular infections.

Composition:
Bactin® Eye Drops : Each ml contains Ciprofloxacin USP 3 mg.
Bactin® Eye Ointment : Each gm contains Ciprofloxacin USP 3 mg.

Indication:
Bactin® Eye Drops or Ointment is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below:
Corneal Ulcer : Pseudomonas aeruginosa, Streptococcus viridans (Drops only), Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Serratia marcescens.
Cojunctivitis : Staphylococcus aureus, Staphylococcus epidermidis, Streptoccoccus pneumoniae. H. influenzae 
Also, Bactin Eye Drops is indicated for prevention of ocular infections after removal of corneal or conjunctival foreign body, after damage from chemical or physical agents, before and after surgery.

Dosage and Administration:
Corneal ulcer : Bactin® Eye Drops: 1st day : Two drops into the affected eye every 15 minutes for the first 6 hours and then 2 drops into the affected eye every 30 minutes for the remainder of the 1st day.
2nd day : Instill 2 drops in the affected eye hourly. 3rd day : On the 3rd through the 14th day, instill 2 drops in the affected eye every 4 hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.
Bacterial Conjunctivitis: Bactin® Eye Drops: 1 or 2 drops instilled into the conjunctival sac(s) every 2 hours while awake for 2 days and 1 or 2 drops every 4 hours while awake for the next 5 days.
Bactin® Eye Ointment: Apply a 1/2" ribbon into the conjunctival sac 3 times daily on the first two days, then apply a 1/2" ribbon two times a day for the next 5 days.

Precaution:
If irritation persists or increases, discontinue the use and consult with the physician. Don't touch the dropper tip to any surface since this may contaminate the solution. Use this solution within 1 month after opening the container. A white crystalline precipitate may be observed in the superficial portion of the corneal defect in patients of bacterial corneal ulcer. But the precipitate will not preclude continued use of Ciprofloxacin, nor will it adversely affect the clinical course of the ulcer or visual outcome.

Pregnancy and Nursing mother:
Safety in pregnancy & lactating mother have not been established. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when Bactin solution is administered to a nursing mother.

Paediatric Use:
Safety & effectiveness in children below the age of 1 year (drops) / 2 year (Ointment) have not been established.

Side effect:
The most frequently reported drug related adverse reaction was local burning or discomfort. Other reactions are lid margin crusting, crystals/ scales, foreign body sensation, itching, conjunctival hyperemia, corneal staining, keratopathy/keratitis, allergic reaction, lid edema, tearing, photophobia, nausea and decreased vision.

Contraindication:
Bactin Eye Drops/Ointment is contraindicated in patients with known hypersensitivity to any of its components.

How supplied:
Bactin® Eye Drops : Plastic dropper bottle contains 5ml or 10 ml drops.
Bactin® Eye ointment : Tube contains 3 gm ointment.

Manufacturer’s Source: IBN SINA

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Bactin - Ciprofloxacin-Antibacterial Film Coated Tablet

Description:
Bactin® is a film coated tablet which is a broad spectrum synthetic Quinolone antiinfective agent. It is active against most of the gram negative aerobic bacteria like Enterobacteriaceae & Pseudomonas aeruginosa and gram positive aerobic bacteria including penicillinase producing, penicillinase nonproducing and Methicillin-resistant Staphylococci. The bactericidal action of Ciprofloxacin results from interfering with the enzyme DNA gyrase.

Composition:
Bactin®Tablet : Each tablet contains Ciprofloxacin USP 250 mg.
Bactin® 500 Tablet : Each tablet contains Ciprofloxacin USP 500 mg.
Bactin® 750 Tablet : Each tablet contains Ciprofloxacin USP 750 mg.

Indication:
Bactin®is indicated for the management of single or mixed infections caused by two or more susceptible microorganisms. It can also be used against infections caused by organisms resistant to other antibiotics. Bactin®is indicated for the treatment of the following infections.
Gastrointestinal tract infection : Enteric fever and infected diarrhoea.
Respiratory tract infection : Pneumonia, acute and chronic bronchitis, cystic fibrosis, bronchiectasis and empyema.
Urinary tract infection : Complicated and uncomplicated urethritis, cystitis, pyelonephritis, prostatitis and epididymitis.
Severe systemic infection : Septicemia, bacteremia, infection in
immunosuppressive patient with hematological or solid tumors.
Skin and soft tissue infection : Wound infection, abscess, infected ulcer, cellulitis, infected burn, erysipelas and otitis externa.
Biliary tract infection : Cholangitis, cholecystitis, empyema of the gall bladder.

Bone and joint infection : Osteomyelitis and arthritis.
Eye, ear, nose and throat infection : Otitis media, sinusitis, mastoiditis and tonsillitis.
Pelvic infection : Salpingitis, endometritis and pelvic inflammatory diseases.
Abdominal infection : Peritonitis & intra-abdominal abscess.
Gonorrhoea : Urethral, rectal and pharyngeal gonorrhoea caused by beta-lactamase producing organisms or organisms moderately sensitive to penicillin.

Dosage and administration:
Adult : The usual adult dose is 250-750 mg twelve hourly.
Adolescent and Children : Generally not recommended but where the benefit is more than potential risk, the dose should be 7.5-15 mg/kg/day depending upon the severity of infection, administered in two divided doses.

Dosage Schedule:

Infection	Dose	Duration
1. Enteric Fever	500 mg	12 hourly 7 -14 days
2. Infected Diarrhoea	500 mg	12 hourly 5 -7 days
3. Chronic Salmonella carriers	500 - 750 mg	12 hourly 28 days
4. Complicated UTI	500 mg	12 hourly 5-7 days
5. Uncomplicated UTI	250 mg	12 hourly 3 -5 days
6. Respiratory Tract Infection	500 - 750 mg	12 hourly 7 -14 days
7. Skin & Soft Tissue Infection	500 - 750 mg	12 hourly 7 -14 days
8. Uncomplicated Gonorrhoea	250 mg	Single dose.
9. Wound Infection	250 mg	12 hourly 7 -14 days
10. Bone & Joint Infection	500 - 750 mg	12 hourly 7 -14 days but may need to continue for 4-6 weeks or longer.
11. Other Infections	500 - 750 mg	12 hourly 7 -14 days

Side effect:
Gastrointestinal disturbances like nausea, vomiting, diarrhoea, dyspepsia and abdominal pain; Disturbances of the CNS eg. dizziness, drowsiness, headache, tiredness, confusion, convulsion, skin rashes, pruritus and possible systemic reactions may occur. It has also been reported that joint pain, mild photosensitivity may occur and liver enzyme, serum bilirubin, creatinine levels may increase slightly.

Contraindication:

Ciprofloxacin is contraindicated in patients with a history of hypersensitivity to it any of its components and to other Quinolones.

Precaution:
Ciprofloxacin should be used with great caution in patient with a known history of epilepsy or other factors which predispose to seizure and convulsion. Patients should be advised to take Ciprofloxacin two hours after meal. Patients should be advised not to take Antacid containing aluminium or magnesium

Bactin® concomitantly or within two hours after dosing and also requested to drink plenty of water.

Pregnancy and lactation:
Ciprofloxacin has been shown to cause arthropathy in immature animals and therefore its use during pregnancy is not yet recommended. It has been reported that Ciprofloxacin is secreted in milk during administration to nursing mother and is thus not recommended yet.

Children & growing adolescents:
The use of quinolones can be considered if it is felt to be necessary by a registered physician, with no suitable alternatives, for a particular clinical situation.

Drug interaction:
Concurrent administration of Ciprofloxacin with theophylline and caffeine may potentiate the adverse effects of theophyline and caffeine. Antacid containing aluminium or magnesium may decrease the bioavailabiltiy of Ciprofloxacin. Quinolones, including Ciprofloxacin, have been reported to enhance the effects of the oral anticoagulantl ike Warfarin or its derivatives.

How supplied:
Bactin®Tablet : Box contains 2 x 10's film coated tablets in blister pack.
Bactin®500 Tablet : Box contains 2 x 10's film coated tablets in blister pack.
Bactin®750 Tablet : Box contains 2 x 10's film coated tablets in blister pack.

Manufacturer’s Source: IBN SINA

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