Franco-Indian Pharmaceuticals Pvt. Ltd.

, a name that stands for quality and innovation, is one of the major players in the Pharmaceutical Industry in India. Our innovative, value added products improve the quality of life of people and ease their sufferings and help them to enjoy, longer, healthier and more productive lives. Franco-Indians strongest attributes are the unwavering focus on ethics, transparency, corporate culture, quality of products, contribution to society and commitment to growth. Franco-Indian is a company that strives to achieve excellence through motivating and empowering it's employees. The HR system is designed with transparency and feedback as the primary pivots of employee evaluation and growth. Given the fact that the company is operating in a knowledge-based industry, FrancoIndian lays a great stress on knowledge management and development as a knowledge-based company through dedicated training programmes for all members of sales, marketing and research teams. Franco-Indian, as a consequence of its better HR practices, has not only attracted some of the finest talents in the industry, but also retained those talents contrary to the common industry practices.

LABORATOIRES GRIFFON PRIVATE LIMITED, MUMBAI : In 1961, FRANCO-INDIAN reached an agreement with LABORATOIRES GRIMAULT, FRANCE to market their specialties in INDIA and subsequently started its own manufacturing unit in MUMBAI. This Company over the years has developed expertise in the manufacture of products for Diabetes, for the treatment of Vitiligo, Psoriasis & Hepatic disorders. Today, LABORATOIRES GRIFFON (earlier LABORATOIRES GRIMAULT) enjoys a major share in Therapeutic segments like Anti- diabetics, Hepatoprotective and Dermatology. WARDEX PHARMACEUTICALS PRIVATE LIMITED, MUMBAI: This Company has manufacturing units at KOLKATA in West Bengal, SAHIBABAD in Uttar Pradesh and CHENNAI in TamilNadu. WARDEX PHARMACEUTICALS PRIVATE LIMITED was established with a view to meet the increasing demand of DEXORANGE SYRUP, the leading Hematinic and also the brand leader in this segment. The objective of this Company was to ensure availability of DEXORANGE SYRUP all over India, keeping logistics of the country in mind. Besides the Anti-anaemic segment, WARDEX PHARMACEUTICALS has a strong presence in the field of Bronchodilators and Cough and Cold preparations with their products GRILINCTUS and GRILINCTUS BM SYP/TABS/PAED.SYP. GRILINCTUS BM is a brand leader in it's segment.

FRANCO-INDIAN REMEDIES PRIVATE LIMITED, CHENNAI: With a view to keep in mind good manufacturing practices as a fundamental rule, this Company was established as a manufacturing unit at CHENNAI and over the years FRANCO-INDIAN REMEDIES has emerged as a successful tablet and liquid manufacturing company.

Today, FRANCO-INDIAN PHARMACEUTICALS PRIVATE LIMITED, besides having its own manufacturing unit at MUMBAI, also utilizes the manufacturing facilities of LABORATOIRES GRIFFON , WARDEX PHARMACEUTICALS and FRANCO-INDIAN REMEDIES and have thus achieved a respectable ranking in the Pharmaceutical Industry of India. Over the years FRANCO-INDIAN PHARMACEUTICALS PRIVATE LIMITED has grown in stature and as on today has over 1200 Employees inclusive of 400 Marketing Professionals, together with a Distribution network of 18 C & F Agents and 1100 Distributors all over India. Today, FRANCO-INDIAN PHARMACEUTICALS enjoys a major share in the therapeutic segments like Hematinics, Antidiabetics, Hepatoprotectives, Dermatology, etc. In the recent past, FRANCO-INDIAN PHARMACEUTICALS has reiterated it's presence in the Antioxidant market by introducing NATVIE-C, MIXCAROTIN, etc. This year, the turnover of FRANCO-INDIAN PHARMACEUTICALS is expected to be in the vicinity of Rs.2.1 billion. The Company is managed by : Chairman Mr. Michel Postel Managing Director Mr. Pascal Postel Directors Mr. E. J. Desouza (Executive Director) Mr. L. B. Yadav Mr. A.G. Sonde Dr. S.D. Sabnis Mr. S.G. Shanbhag Mr. J. O. Chavda Mr. A. K. Chatterjee

Head Office 20, Dr. E. Moses Road, Mumbai : 400 011

Distribution Office 676 - 680, Bapurao Jagtap Marg

Factory 54-B, Sir M. Vasanji Road Mumbai : 400 093.

Tel: 91-22-2493 4026/27/30 Fax: 91-22-2495 0557

Mumbai : 400 011. Tel : 91-22-2820 3699 Tel : 91-22-2308 4061 Fax: 91-22-2307 8581 Email:francoip@bom7.vsnl.net.in Franco-Indian Pharmaceuticals during the past 50 years have successfully introduced several valuable products to the medical profession in India. ' Therapeutic Index ' briefly details a few of the most important products that we are currently marketing. Antidiarrhoeals

Amicline Tablets Amicline Plus Tablets

AMICLINE Tablets
Composition: Each uncoated tablet contains : Diloxanide Furoate I.P................. 500 mg. Description: AMICLINETablets contain Diloxanide Furoate which is a luminal amoebicide with good efficacy against the trophozoite and cystic forms of E. histolytica present in the intestinal lumen. Diloxanide Furoate is a dichloroacetamide derivative. After oral administration, high concentrations are reached in the intestinal lumen. Hence, it is very effective against the amoebic cysts and trophozoites in the lumen. It is well-tolerated and can be used in pregnancy. Its anti-amoebic efficacy is comparable to that of nitroimidazoles. Hence, it can be used in patients with intestinal amoebiasis, where nitroimidazoles are ineffective or are contraindicated. Indications: Asymptomatic cyst passers. In combination with tissue amoebicides for complete cure of amoebiasis. Anti-amoebic therapy, where: (a) Patients are allergic to nitroimidazoles. (b) Patients cannot tolerate the bad taste of nitroimidazoles. (c) Patients get moderate to severe GI disturbances with nitroimidazoles. (d) Patients are predisposed to CNS diseases, seizures or blood dyscrasias.

(e) Patient with recurrent amoebic colitis, where it is not safe to use nitroimidazoles repeatedly. (f) Patient who are pregnant or lactating (After accessing riskbenefit ratio). Intestinal amoebiasis. In invasive (extra-intestinal) amoebiasis in conjugation with tissue amoebicide.

Dosage: Adults Children -

1 tablet 3 times a day for 10 days, after meals. 20 mg/kg body wt/day in divided doses for 10 days, after meals.

Side Effects: Diloxanide Furoate is well-tolerated and the side effects observed with it are mild. These mainly consist of flatulence, anorexia, nausea, vomiting and pruritus. Precautions: No special precautions are required. Presentation: AMICLINE Tablets are available in a blister strip of 10 tablets. 10 such strips in a carton.

AMICLINE Plus Tablets Composition: Each compression coated tablet contains : Tinidazole I.P. 300 mg. Diloxanide Furoate I.P. 375 mg. Dicyclomine Hydrochloride I.P. 5 mg. Colour : Lake of Quinoline Yellow. (C.I. No. 47005) in the coat. Description: Parasitic diseases are endemic in our country. The mainstay of therapy is a mixed therapy with a nitroimidazole plus Diloxanide Furoate supplemented by Dicyclomine. Tinidazole is a nitroimidazole, that is well-absorbed from the small intestine to achieve high bioavailability in blood, liver and other extra-intestinal tissue sites. It attacks Entamoeba at all these sites. However, its concentration in the large intestine is not always optimum to ensure eradication of all trophozoite forms of the protozoa. Hence, an effective luminal amoebicide like Diloxanide Furoate is needed to supplement the action of nitroimidazoles to complete the eradication of Entamoeba. Amoebic colitis is accompanied by tenesmus and recurrent

gripes, due to diffuse ulceration of the colonic walls. Thus, Dicyclomine, which is an effective smooth muscle relaxant has been used to relieve such discomfort. Indications: In diarrhoeas of amoebic etiology. Intestinal amoebiasis. Extra-intestinal amoebiasis. Asymptomatic cyst passers. Giardiasis. Dosage: Adults - 2 tablets 2 times a day for 5 days, after meals or as directed by the physician. Children - As directed by the physician. Contraindications: Use of AMICLINE PLUS in the first trimester of pregnancy and lactation is not recommended. Side Effects: Tinidazole is generally well-tolerated, but occasionally the side effects seen are headache, nausea, dry mouth, metallic taste and dark coloured urine. Diloxanide Furoate is also well-tolerated and the side effects observed with it are mild. These mainly consist of flatulence, anorexia, nausea, vomiting and pruritus. Dicyclomine Hydrochloride has long been in use. It is well-tolerated with reports of occasional side effects like blurring of vision, dryness of mouth, thirst, photophobia and arrhythmias which occur rarely. Precautions: Tinidazole can give rise to an antabuse reaction when consumed with alcohol. Hence, alcohol should be avoided. Presentation: AMICLINE PLUS Tablets are available in a blister strip of 10 tablets. 10 such strips in a carton.

Hematinic
Dexorange Syrup Dexorange Capsule Dexorange Paediatric Syrup DEXORANGE Syrup Composition: Each 15 ml. (one tablespoonful) contains : Ferric Ammonium Citrate I.P. 160 mg.

(equivalent to elemental iron 32.8 mg.) Cyanocobalamin (Vitamin B12) I.P. 7.5 mcg. Folic Acid I.P 0.5 mg. Alcohol (95%) I.P. 0.87 ml. Colour : Erythrosine (Colour Index No. 45430) Caramel I.P. Adequate overages of vitamins added to compensate for the loss on storage. Alcohol content 5.5% v/v Description: DEXORANGE Syrup is a welltolerated complete hematinic. It provides a comprehensive treatment for all types of nutritional anemias. Every 15 ml (one tablespoonful) of this deliciously flavoured syrup provides 32.8 mg of elemental iron. The formula of DEXORANGE Syrup treats anemias of multifactorial etiology by faster correction and rapid replenishment of tissue iron stores. In tropical countries like India, where dimorphic anemias are common, the addition of Folic Acid and vitamin B12 in therapeutic doses make DEXORANGE Syrup an ideal hematinic.

Indications: Iron deficiency anemia due to chronic blood loss, hook-worm infestations; inadequate intake of iron, etc. Dimorphic anemia due to deficiency of Iron, Folic Acid and/or vitamin B12. Anemia of pregnancy and lactation. Tonic in general weakness, lack of appetite, rundown conditions and convalescence. Post surgery and other debilitated states.

Dosage: Adults (Therapeutic) : 1 tablespoonful twice a day after meals. Children (above 1 year) : As advised by the Physician. Presentation: Bottle of 200 ml.

DEXORANGE CAPSULE Composition: Each soft gelatin capsule contains : Ferric Ammonium Citrate I.P. 160 mg. (equivalent to elemental iron 32.8 mg.) Vitamin B12 I.P. 7.5 mcg. Folic Acid I.P. 0.5 mg. Zinc Sulphate Monohydrate U.S.P. 20.61 mg. (equivalent to elemental Zinc 7.5 mg.) Colour - Ponceau 4R (CI No. 16255) and Titanium Dioxide Adequate overages of vitamins added to compensate for the loss on storage. Description: DEXORANGE capsules provide 32.8 mg. of elemental iron per capsule. It is especially formulated after doing extensive clinical trials, to yield an adequate amount of elemental iron, for a rapid rise in hemoglobin levels. At the same time, it is well-tolerated and has a minimum of side effects. Moreover, DEXORANGE capsules contain Folic acid, vitamin B12 and zinc in therapeutic doses. Zinc supplementation reduces the incidence of pre-term delivery, very low birth weights in infants. It also helps in protein synthesis, cell growth and immune functions. Thus, DEXORANGE capsules offer a comprehensive treatment and a convenient way to treat patients with nutritional anemia. Indications: Anemia of pregnancy and post-natal period. Anemia resulting from menorrhagia. Anemia associated with poor intake of food and hook-worm infestations. Anemia manifested by generalised weakness. Anemia associated with peptic ulcer, piles, etc. Anemia in post-operative and post-traumatic conditions. Dosage: Adults (Therapeutic) : One capsule twice a day after meals. Presentation: Bottle of 30 capsules.

DEXORANGE PAEDIATRIC Syrup Composition: Each 5 ml. (one teaspoonful) contains :

Ferric Ammonium Citrate I.P. 50 mg. (equivalent to elemental iron 10.25 mg.) Protein 0.333 gm. Cyanocobalamin (Vitamin B12) I.P. 2.5 mcg. Folic Acid I.P. 200 mcg. Colour : Caramel I.P. Adequate overages of Vitamins added to compensate for loss on storage. Description: The estimated prevalence of anemia in India amongst pre-school children is 70%. ICMR has shown that as many as 63% of children belonging to 1-3 years age group and 44% between 3-5 years of age have subnormal hemoglobin levels. Iron deficiency and iron deficiency anemia during infancy and early childhood have been associated with abnormal infant behaviour, growth, and development. In children, iron deficiency is commonly due to increased physiological demand of iron during the growth and development. Deficiencies of iron in diet and hook-worm infestations are other common causes of iron deficiencies in developing and tropical countries including Indian subcontinent, particularly in rural areas. When nutritional iron deficiency coexists with deficiency of Cyanocobalamin, Folic acid and protein, it leads to dimorphic type of anemia. DEXORANGE Paediatric Syrup thus provides iron in the form of Ferric Ammonium Citrate equivalent to 10.25 mg. of elemental iron, which is one of the best tolerated iron supplements. It rapidly supplements elemental iron so that iron deficiency is quickly controlled, leading to faster correction of anemia and replenishment of tissue iron stores. DEXORANGE Paediatric Syrup also provides good quality protein containing all the essential amino acids, necessary for globin formation and to meet the demand in growing children. However the main reason for adding protein in DEXORANGE Paediatric Syrup is to enhance the utilization of iron supplement. Since Indian diet is predominantly vegetarian, it lacks Cyanocobalamin (Vitamin B12). DEXORANGE Paediatric Syrup provides Cyanocobalamin and Folic Acid, which are the most important hematinic factors essential for maturation of red blood cells and to treat nutritional deficiency anemia. Indications: Iron deficiency anemia due to inadequate absorption, hook-worm infestations, inadequate intake of iron, etc. Dimorphic anemia due to deficiency of Iron, Folic Acid and/or Vitamin B12. Tonic in general weakness, lack of appetite, rundown conditions and convalescence.

Post surgical anemia.

Dosage: As advised by the physician. Side Effects: This dose of iron is usually well-tolerated and very few side effects are reported. Occasionally upper abdominal discomfort and lower gastrointestinal symptoms like constipation or diarrhoea are observed. Presentation: DEXORANGE Paediatric Syrup is available in a delicious orange flavoured syrup, in bottle of 60 ml with measuring cup for better patient acceptability.

Cough Formulations
Grilinctus BM Paediatric Syrup Grilinctus BM Tablets/Syrup Grilinctus Syrup

GRILINCTUS-BM Paediatric Syrup Composition: Each 5 ml contains : Terbutaline Sulphate I.P. 1.5 mg Bromhexine Hydrochloride I.P. 4 mg Flavoured Syrup Base q.s. Description: Grilinctus-BM Paediatric Syrup is a combination of Terbutaline and Bromhexine. Terbutaline is a selective bronchodilator devoid of significant side effects on the cardiovascular system, when taken in correct dosage and Bromhexine is an ideal mucolytic agent. Thus administration of Grilinctus-BM Paediatric Syrup to patients suffering from cough in bronchial asthma, moderate to severe bronchiolitis, and other bronchospastic disorders, serves a dual purpose of opening up the airways, as well as clearing up the airways by facilitating expulsion of sputum. Grilinctus-BM Paediatric Syrup is specially formulated for children. It does not contain any colouring agent.

Indications: Bronchial asthma. Bronchiolitis. Other bronchospastic disorders. Dosage: Children (2-6 yrs) : 1/2 - 1 tsp. three times a day or as directed by the physician. Children (6-14 yrs) : 1 - 2 tsp. three times a day. Side Effects: When used in the recommended dosage, Grilinctus-BM Paediatric Syrup is well-tolerated with rare side effects. Gastrointestinal intolerance is occasionally seen. Tremors and palpitations may be noted, particularly in those taking high doses. Precautions: Grilinctus-BM paediatric syrup should be administered with caution in thyrotoxic patients. Presentation: Grilinctus-BM paediatric syrup is presented in a 30 ml. bottle.

GRILINCTUS-BM Tablet / Syrup

Composition: Grilinctus - BM Syrup Each 5 ml contains : Terbutaline Sulphate I.P. 2.5 mg Bromhexine Hydrochloride I.P. 8 mg Flavoured Syrup Base q.s. Colour: Sunset Yellow FCF (Colour Index 15985) Grilinctus - BM Tablets Each uncoated tablet contains : Terbutaline Sulphate I.P. 2.5 mg Bromhexine Hydrochloride I.P. 8 mg Description: Terbutaline is a selective 2 agonist, used as a bronchodilator for reversible airway obstruction. It is preferred over Salbutamol because it has less cardiovascular side effects and less tremors, headache and insomnia. Also, as Terbutaline has a longer duration of action of 8 hours, this is preferred to control nocturnal asthma and requires less frequent dosing, thus improving patient compliance.

Bromhexine is a synthetic benzylamine derivative of vasicine, an alkaloid derived from the plant Adhatoda vasica. It is a mucolytic agent, rendering the sputum less viscous thereby facilitating easy expulsion from the respiratory tract. It should be considered as the drug of choice in conditions associated with productive cough.

Indications: Bronchial asthma. <="" font="">

Indications: For symptomatic treatment of cough and cold in: Common cold. Pulmonary tuberculosis. Vasomotor rhinitis. Pneumonia. Smoker's cough. To suppress irritable Acute and chronic bronchitis. unproductive cough as in Allergic bronchitis. mediastinal compression. Whooping cough. Reflex cough, etc. Bronchiectasis.

Dosage: Adults : 1-2 tsp. 3 to 4 times a day. Children : Proportionately lesser dosage depending upon the age or as prescribed by the Physician. Precautions: As compared to many other antihistamines, Chlorpheniramine maleate produces drowsiness of lesser severity in lesser percentage of patients. However, those taking GRILINCTUS syrup, particularly in higher dosages, should avoid drinking alcohol, operating machinery and other activities requiring alertness. Drug Interactions: Alcohol, sedatives and tranquilizers should be avoided while the patient is on GRILINCTUS syrup, as Chlorpheniramine maleate may potentiate CNS depression produced by these agents. Presentation: Bottles of 100 ml. and 450 ml.

Calcium Supplements
Omilcal Suspension Omilcal Tablets

OMILCAL SUSPENSION Composition: Each 10ml. (2 tsp.) contains : Tribasic Calcium Phosphate as microsuspension equivalent to [Ca3 (PO4)2] 130 mg. Calcium Lactate I.P 310 mg. Vitamin D3I.P. (Cholecalciferol) 400 I.U. Vitamin B12 I.P. 5 mcg. Sunset Yellow FCF (Colour Index 15985) Excipients q.s. Adequate overages of Vitamins added to compensate for loss on storage. Description: OMILCAL is a unique calcium tonic containing Calcium Phosphate in micro-suspension form, which ensures better absorption. It contains 39% elemental Calcium. In addition, OMILCAL also contains soluble Calcium Lactate which is rapidly absorbed from the gastrointestinal tract. Calcium is essential for functional integrity of neuromuscular tissue. It is also required for proper cardiac functions and is one of the important factors that operate in the mechanism of coagulation of blood. Calcium deficiency states are favorably modified by Calcium preparations and Vitamin D3. Presence of Vitamin D3 ensures better absorption and utilization of calcium. Indications: Calcium deficiency disorders in children.

Calcium supplement in pregnant women and nursing mothers. As a tonic in neurasthenia and neuromuscular debility. As an adjunct in the treatment of fractures and pulmonary tuberculosis. Various conditions associated with capillary haemorrhage e.g. post-operative haemorrhage. As a general tonic in convalescence. Certain skin diseases like chronic eczema often respond to OMILCAL therapy.

As a tonic in children with poor growth rate. In old age for calcium supplementation.

Dosage: Adults (Therapeutic) : 10 ml. (2 teaspoonful) twice a day. Children (above 1 year) : As advised by the physician. Contraindications: Hypercalcaemia, severe renal failure and severe hypercalciuria. Precautions: In chronic renal failure and mild hypercalciuria (more than 300 mg/24 hours) or in patients with history of stone formation in the urinary tract, adequate checks should be kept on urinary calcium excretion. Presentation: Bottle of 200 ml. OMILCAL TABLETS Composition: Each chewable tablet contains : Dibasic Calcium Phosphate I.P. 400 mg. Vitamin B12 I.P. 2.5 mcg. Vitamin D3 I.P. (Cholecalciferol) 200 I.U. Sunset Yellow (Lake) FCF (Colour Index No. 15985) Adequate overages of vitamins added to compensate for loss on storage. Description: OMILCALTablets are a judicious combination of Calcium, Vitamin D3 and Vitamin B12 . Dibasic Calcium Phosphate is a valuable source of both Calcium and Phosphate. It provides 23% elemental Calcium. Calcium is one of the most important elements required by the body. Calcium is essential for the functional integrity of neuromuscular tissue, for normal bone and teeth formation and for maturation of cartilage cells. Calcium is also required for proper cardiac function and is one of the important factors needed for coagulation of blood. Phosphate plays an important role in modifying the concentration of Calcium ions in tissue. Moreover, Phosphate ions are buffers of the intracellular fluid and play a primary role in the renal excretion of H+. The proper absorption of Calcium depends upon the availability of Vitamin D3 (Cholecalciferol). In the absence of Vitamin D3, the absorption of Calcium from the intestine is impaired. Vitamin B12 improves appetite, vigour and gives a sense of well-being.

In short, OMILCAL Tablets provide the essential elements necessary for the growth and maintenance of healthy tissues. Indications: Osteoporosis due to menopause/old age. Drug/diet induced osteoporosis. Low back pain/skeletal pain due to aging. As an adjunct in the treatment of fractures. For foetal mineralisation during pregnancy. Osteomalacia of pregnancy and lactation. Cramps/spasms of muscles due to Calcium deficiency. Certain skin diseases like chronic eczema. Dosage: Adults (Therapeutic) : 2 tablets twice a day. Children (above 1 year) : 1 tablet twice a day. Contraindications: Hypercalcaemia, severe renal failure and severe hypercalciuria. Precautions: In chronic renal failure and mild hypercalciuria (more than 300 mg/24 hours) or in patients with history of stone formation in the urinary tract, a check should be kept on urinary calcium excretion. Presentation: Bottle of 100 tablets.

Dermatological
Surfaz-SN Cream Surfaz Ear Drops/Cream/Powder/Solution Surfaz Vaginal Tablets Melanocyl Tablet / Solution / Ointment Paraminol Ointment SURFAZ-SN Cream Composition: Clotrimazole I.P. 1.0% w/w. Betamethasone Dipropionate U.S.P. equivalent to Betamethasone 0.05% w/w. Neomycin Sulphate I.P. 0.5% w/w. Cream base q.s. Description: Betamethasone Dipropionate is a higly potent fluorinated topical corticosteroid. It has prompt antiinflammatory, antipruritic and vaso-

constrictive action. By these actions, it promptly controls symptoms such as itching, redness and scaling. Clotrimazole is a broad spectrum synthetic antifungal agent having fungicidal action against all the fungi responsible for superficial fungal infections of the skin. It is a synthetic imidazole derivative. Neomycin sulphate is an antibiotic having a broad spectrum of action and is very well-tolerated when applied topically. Since Neomycin sulphate is never used as a systemic antibiotic, it is ideally suited for topical use. Indications: SURFAZ-SN is indicated in the treatment of various inflammatory dermatological disorders superadded with bacterial or superficial fungal infections of the skin. Dosage & Administration: SURFAZ-SN should be thinly and evenly applied to the affected area, two or three times a day with a gentle rub. Contraindications: 1. Hypersensitivity to any of the ingredients. 2. Viral or tubercular infections of the skin. Presentation: SURFAZ-SN is available in a tube of 7 gms. SURFAZ Cream/Ear Drops/Solution/Powder Composition:

SURFAZ Cream Clotrimazole I.P. 1% w/w. Cream base q.s. SURFAZ Ear Drops Clotrimazole I.P. 1% w/v. Lidocaine U.S.P. 2% w/v. SURFAZ Solution Clotrimazole I.P. 1% w/v. SURFAZ Dusting Powder Clotrimazole I.P. 1% w/w. Description: SURFAZ contains Clotrimazole, which is a synthetic imidazole derivative. It is a broad spectrum antifungal agent and has fungicidal activity against all the fungi responsible for superficial mycotic skin infections. It also has activity against certain gram-positive bacteria such as Streptococci and Staphylococci. In day-to-day practice, a medical practitioner comes across many cases of superficial fungal infections of the skin. Ringworm infections as well as dermal candidiasis are very common in hot and humid areas. Interdigital

spaces, groin and perianal areas are common sites for ringworm infections, as well as, dermal candidiasis. Sometimes it is not possible to differentiate between them only on physical examination and adequate laboratory facilities may not be available. It is always wise to use an antifungal agent having activity against ringworm as well as Candida albicans. Hence SURFAZ is the drug of choice in the treatment of fungal infections of the skin. Indications: Ring worm infections. Dermal candidiasis. Pityriasis versicolor. Erythrasma. Fungal infections of the external ear. Contraindications: Hypersensitivity to Clotrimazole. Mode of Application: SURFAZ Cream should be thinly and evenly applied to the affected area, two or three times daily and rubbed in gently. SURFAZ Solution should be preferred in patients having lesions covering large and hairy areas. The treatment should be continued for atleast one month or atleast two weeks after disappearance of all signs of infections. If the feet are infected, they should be properly washed and dried particularly between the toes before applying SURFAZ. SURFAZ Solution can be used in the treatment of oral candidiasis (Thrush). For Otomycosis (fungal infections of the external ear), SURFAZ Ear Drops should be used. In patients prone to get repeated fungal skin infections, SURFAZ Dusting powder should be applied to the areas prone to fungal skin infections, such as axilla, groin, interdigital areas and in other affected areas. Precautions: SURFAZ Ear Drops 1. In patients having perforated ear drums, application of SURFAZ Ear Drops in the external ear should be avoided. 2. SURFAZ range is not meant for ophthalmic use. Presentation: SURFAZ Cream: Tube of 15 gm. SURFAZ Ear Drops: Plastic Bottle of 10 ml. SURFAZ Solution: Plastic Bottle of 15 ml. SURFAZ Dusting Powder: Plastic Container of 30 g.

SURFAZ VAGINAL TABLETS Composition: Each Vaginal Tablet contains :

Clotrimazole I.P 100 mg. Description: SURFAZ Vaginal Tablets contain Clotrimazole which is a broad spectrum antifungal agent having fungicidal action against all the species of Candida. In addition, it has cidal action against Trichomonas vaginalis and gram-positive bacteria. Due to lack of laboratory facilities, many times it is not possible to isolate the causative organism responsible for vaginitis in a given case. Moreover, in many patients, vaginitis is of mixed etiology. Hence SURFAZ Vaginal tablet is the drug of choice in the treatment of vaginitis. Dosage Schedule: One SURFAZ Vaginal Tablet should be inserted high up in the vagina daily just before retiring, for 6 consecutive nights. The treatment may be extended upto 12 days, if required. The treatment should not be carried on during menstrual period. If the patient is also suffering from Candida vulvitis, the affected area should be treated with SURFAZ Cream/Solution. In order to prevent reinfection, the partner should be treated with local application of SURFAZ Cream on the glans penis. Precautions: As far as possible, SURFAZ Vaginal Tablets should not be used in the first trimester of pregnancy. Presentation: Strip of 6 tablets in a carton, provided with an applicator. MELANOCYL TABLETS/SOLUTION/OINTMENT

Composition: MELANOCYL Tablets Each uncoated tablet contains : Methoxsalen U.S.P. 10 mg. (Ammoidine) MELANOCYL Topical Solution Methoxsalen U.S.P. 1% w/v Propylene Glycol base q.s. MELANOCYL Ointment Methoxsalen U.S.P. 0.75% w/w. (Ammoidine)

Aminobenzoic Acid B.P. 2% w/w. Description: Photochemotherapy is a recent trend in the treatment of psoriasis and vitiligo. It is a therapeutic approach based on the interaction of light and a photo-active drug, Methoxsalen, to bring about beneficial therapeutic results in a biological system. Photochemotherapy with Psoralens, (a group of drugs to which Melanocyl belongs), and ultraviolet light is briefly termed as PUVA. The drug of choice in photochemotherapy is Methoxsalen or 8-Methoxypsoralen (MELANOCYL). Methoxsalen (MELANOCYL) belongs to the furocoumarin group of organic chemical compounds and is a photosensitising agent. When combined with exposure to long wave ultra-violet rays, Methoxsalen is very useful in the treatment of psoriasis and vitiligo. Indications: Psoriasis. Vitiligo. Oral therapy (MELANOCYL Tablets) DOSAGE / EXPOSURE SCHEDULE IN PSORIASIS : When given to patients of psoriasis, Methoxsalen inhibits the DNA synthesis in rapidly multiplying cells in psoriatic patches thus helping remission. All types of psoriasis can be treated with Methoxsalen (MELANOCYL). However, patients having erythrodermic psoriasis should be kept under close supervision. The recommended dose is 0.6 mg. per kilogram body weight, to be taken on alternate days preferably with a glass of milk or bland diet in a single dose. This is to be followed two hours later by exposure to sunlight or artificial ultra-violet light, as peak blood levels of Methoxsalen are reached between 1 to 3 hours after ingestion. We recommend the following dosage :

Weight of the Patient Less than 30 kg. 30-50 kg. 50-65 kg. 65-80 kg. More than 80 kg.

TABLE - I Melanocyl in mg. No. of Tabs. (10 mg.) 10 mg. 1 20 mg. 2 30 mg. 3 40 mg. 4 50 mg. 5

We recommend the following exposure schedule for Psoriasis :

No. of Exposurres 1

Table - II Day Exposures to sunlight in minutes 1 5 mins.

2 3 4 5 6 7 8 9 10 11 12 Upto the recommended number of exposures or remission

4 6 8 10 12 14 16 18 20 22 24

10 15 20 25 30 30 30 30 30 30 30

mins. mins. mins. mins. mins. mins. mins. mins. mins. mins. mins.

There should be a gap of 72 hours between the first and second exposure. This allows sufficient time for the effect of the first dose of Methoxsalen to wear out before the second dose. This is done in order to study the reactions, if any, in the form of itching, burning or blistering which will vary from individual to individual. For solar radiation, the best exposure time is when the sun is at its zenith (i.e., 11.30 a.m. to 1.30 p.m.). The patient should be in lying down position. If the patient has a tendency to sleep, someone must wake him or the patient must use an alarm clock. With 20-40 exposures (mean: 30 exposures), 80% of patients will have good remission. Maintenance Therapy for Psoriasis Psoriatic patients should be given one exposure per week and gradually frequency of exposure should be reduced. Those patients who develop moderate or gross recurrence during the maintenance treatment should be put on initial treatment again. Dosage/Exposure Schedule in Vitiligo In vitiligo, Methoxsalen concentrates in MELANOCYTES and initiates the production of melanin when the cells are activated by ultra-violet light. The increase in pigment occurs gradually over several days or weeks of repeated exposures. For patients with vitiligo, we recommend the dosage of melanocyl Tablets as in Table-I. However, since vitiligo patients lack the melanin pigment, their skin is more sensitive to ultra-violet light. Hence the exposure schedule recommended is as follows : Table - III Day Light dose in minutes 1 5 mins. 4 5 mins. 6 5 mins. 8 7 mins.

No. of Exposurres 1 2 3 4

5 6 7 8 9 10 11 12 13 14 15 16 17 Upto the recommended exposures

10 12 14 16 18 20 22 24 26 28 30 32 34

7 mins. 7 mins. 10 mins. 10 mins. 10 mins. 12 mins. 12 mins. 12 mins. 15 mins. 15 mins. 15 mins. 20 mins. 22 mins.

There should be a gap of 72 hours between the first and second exposure. This allows sufficient time for the effect of the first dose of Methoxsalen to wear out before the second dose. This is done in order to study skin reactions, if any, in the form of itching, burning or blistering, which will vary from individual to individual. For solar radiation, the best exposure time is when the sun is at its zenith (i.e., 11.30 a.m. to 1.30 p.m.) Good repigmentary response is achieved in approximately 50% of cases. Repigmentation may begin after a few weeks or may take as long as 3-6 months. Some cases may require maintenance dosage to retain the new pigment. The face, trunk, arm, forearm, thighs and legs show very good response. Areas like hands, feet, palms, soles, lips, mucous membrane, segmented vitiligo, hairless areas or patches with white hair, show poor response. Patients with acute progressive vitiligo with more than 50% body involvement are not advised any treatment. Maintenance Therapy For Vitiligo Patients with vitiligo are given 3 exposures per week in the initial period and depending upon the response, the duration of exposure is to be adjusted. Use of Paraminol Paraminol Ointment should be applied on the periphery of the vitiliginous patch to give protection to the surrounding areas of normal skin. Adverse Reactions: Extensive clinical experience has shown that orally administered Methoxsalen is well-tolerated and there are no reported cases of any adverse effects. Side effects may occur in a few patients but these can be minimised if the tablets are taken after light snacks. If the symptoms like nausea, vomiting etc. still persist, the dose may be

split in two and the second dose taken at an interval of half an hour from the first. Precautions: Patients should wear dark optical glasses during exposure. The protective eye wear must be designed to prevent entry of ultra-violet radiation to the eyes, including that which may enter from the sides of the eyewear. People working outdoors are advised to cover their bodies with full clothing, and wear proper headgear when going out in the sun. Contraindications: 1. Patient having photosensitising dermatitis. 2. Pregnant women. 3. Children less than 12 years. 4. Patients with melanoma or with a history of melanoma. Topical Therapy (MELANOCYL Solution/Ointment) MELANOCYL is available as solution and ointment. Ointment is especially recommended for delicate and sensitive skin. Ointment form is also indicated when the skin is too dry. For lesion in hairy areas, solution is to be preferred. Indications for Topical Therapy: MELANOCYL Solution and Ointment should be used in the treatment of vitiligo in certain conditions, such as : The patches are small and localised. The patient cannot tolerate oral therapy. Children less than 12 years. The patient has had a recent attack of hepatitis. The patient is suffering from any renal disease. NOTE : Solution or Ointment can be combined with Oral therapy for better results. Dilution: MELANOCYL Solution and Ointment should be diluted at the start of therapy. Undiluted medicine, if applied, can cause severe irritation. The exact dilution used will vary, according to skin colour and sensitivity, and location of the patches. For eg. in a fair person, higher dilution (lower concentration) must be used. The face can tolerate lower concentrations compared to the hands and feet. As a general guideline, it is recommended that one part of MELANOCYL should be mixed with 9 parts of Vaseline (in the case of Ointment) or 9 parts of Eau de cologne (in the case of Solution). As the medicine starts working and the patient's tolerance power increases, the proportion of the active medication may be increased. Mode of Application: MELANOCYLSolution or Ointment should be applied on alternate days only. Before applying, wash the patches with soap and water. Apply PARAMINOL Ointment on the periphery of the vitiliginous patch to prevent accidental spilling of the medicine on normal skin

and also to prevent hyperpigmentation. Care should be taken to apply the correct dilution of the medicine. Apply the Solution/Ointment with a brush, cotton or fingers. Wash the fingers after application. One hour after application, expose the areas to sunlight (see below). After sunlight exposure, wash all the medicine from the patches and apply PARAMINOL Ointment.

Exposure Schedule for Topical Treatment: This will differ with every patient. As a broad guideline, expose the skin for one minute only in the first week. Then increase the duration of exposure by 2 minutes every week, till redness appears on the patch. Once the patch becomes red, do not increase the duration of exposure further. Once redness subsides, again increase duration. Do not increase duration to more than 15 minutes. Note : When using the combined treatment i.e. topical+oral, please follow the exposure schedule mentioned under `Topical therapy' and disregard the exposure schedule mentioned under `Oral Therapy'. Precautions : In addition to the precautions mentioned for MELANOCYL Tablets, the following need to be kept in mind : 1. If at any stage, the patch shows blistering or ulceration stop applying the medicine as well as advise to stop ultra violet exposure from sunlight or artificial light, till the inflammation subsides. Apply any cold cream or hydrocortisone or betamethasone dipropionate cream to reduce inflammation and discomfort. This should be done under medical supervision. 2. Do not apply the medicine on eyelids, lips, inside the mouth or on genitals. 3. Keep the medicine away from children. 4. If after six months of continuous treatment there is no improvement at all, discontinue the medicine.MELANOCYL Solution/Ointment should be used under the advice and supervision of a physician only. Presentation: MELANOCYL Tablets Blister pack of 40 tablets. 5 such packs in a carton. MELANOCYL Solution Vial of 25 ml. MELANOCYL Ointment Tube of 25 gms. PARAMINOL Ointment

Composition: Aminobenzoic Acid B.P. 10% w/w. Excipients q.s. Description: PARAMINOL is an anti-actinic ointment containing 10% aminobenzoic acid. It is non-greasy and non-staining to the clothes. The action of PARAMINOL is very safe, effective and without any disruption or interference in the normal formation of melanin, by the conversion of tyrosine to DOPA, as might be caused with monobenzyl ether of hydroquinone. PARAMINOL filters UVB rays and prevents its damaging effects on skin. Indications: PARAMINOL is an essential adjunct in the treatment of vitiligo by MELANOCYL group. PARAMINOL prevents pigment darkening of the normally coloured skin at the border area. Apply a thin film of PARAMINOL ointment on the periphery of the vitiliginous patch. It is very essential to protect the area of normal skin in the neighbourhood of the patches in order to avoid hyperpigmentation of the border of the patches which are treated. PARAMINOL can also be used in the prevention and treatment of radiation dermatitis induced by solar radiation and to prevent premature aging of skin due to over-exposure to sunlight. Presentation: PARAMINOL Ointment is available in a tube of 25 gms.

Oral Antifungal
SURFAZ-O Tablets Composition: Each uncoated tablet contains : Fluconazole USP .150mg Colour : Lake of Ponceau 4 R (CI-16255)

Description: Fluconazole, is a member of the bistriazole antifungal agents. Fluconazole is a highly selective inhibitor of fungal cytochrome P-450 sterol C-14 alpha demethylation. Mammalian cell demethylation is much less sensitive to Fluconazole inhibition. The subsequent loss of normal sterols correlates with the accumulation of 14 alpha-methyl sterols in fungi and may be responsible for the fungistatic activity of Fluconazole. Interaction studies with antipyrine indicate that single or multiple doses of Fluconazole 50 mg do not affect its metabolism. Fluconazole is well absorbed and oral absorption is not affected by concomitant food intake. In fasted normal volunteers, peak plasma concentrations occur between 1 and 2 hours post dose with a terminal plasma elimination half-life of approximately 30 hours (range 20-50 hours). The apparent volume of distribution approximates to total body water. Plasma protein binding is low (11-12%). Fluconazole has been found to achieve good penetration into all tissues and body fluids studied. The levels of Fluconazole in saliva and sputum are similar to plasma levels. The major route of excretion is renal, with approximately 80% of the administered dose appearing in the urine as unchanged drug. About 11% of the dose is excreted in the urine as metabolites. The pharmacokinetics of Fluconazole are markedly affected by reduction in renal function, however, no adjustments in single-dose therapy are necessary. There is an inverse relationship between the elimination half-life and creatinine clearance. The long plasma elimination half-life provides the basis for single dose therapy for vaginal candidiasis. Fluconazole administered orally was active in a variety of animal models of fungal infections using standard laboratory strains of fungi. Fluconazole exhibits in vitro activity against Cryptococcus neoformans and Candida species. Activity has been demonstrated in vivo in normal and immunocompromised animals against infections with Candida species, including systemic candidiasis and in normal animals with C. neoformans, including intracranial infections. The efficacy of Fluconazole in vivo is greater than would be apparent from in vitro testing against the abovementioned fungi. Indications:

SURFAZ-O given orally, is indicated for vaginal candidiasis. Dosage:

Adults: For vaginal candidiasis, SURFAZ-O should be administered as a single oral dose. Children: Single dose Fluconazole is not recommended for use in children under 18 years of age except under doctors supervision. Contraindications: Fluconazole 150mg tablets should not be used in patients with known sensitivity to Fluconazole, to related azole compounds or to any of its excipients. Concomitant administration with Cisapride is contraindicated. Side Effects: Fluconazole is generally well-tolerated. Commonly reported side effects observed during vaginal candidiasis clinical trials and associated with Fluconazole with an incidence >1% are: Headache, nausea, abdominal pain, vomiting, skin rash and diarrhoea. Mild transient, reversible increase in liver enzymes like ALT, AST, alkaline phosphatase and serum albumin, etc. may be seen. Serious hepatotoxicity is rarely seen. Clinical adverse reactions have been more frequently reported in HIV infected patients than in non-HIV infected patients, however, the patterns were similar. In rare cases, anaphylaxis has been reported. Drug Interactions: Anticoagulants: Fluconazole has been shown to prolong prothrombin time of coumarin drugs, hence requires careful monitoring. Rifcin: Concomitant administration of Fluconazole and Rifampicin resulted in a 25% decrease in AUC and a 20% shorter half-life of Fluconazole in normal volunteers. Theophylline: Fluconazole decreases the mean plasma clearance of Theophylline. Patients who are receiving high dose Theophylline or who are otherwise at increased risk of Theophylline toxicity should be observed for signs of Theophylline toxicity while receiving Fluconazole and therapy modified appropriately if signs of toxicity develop. Cisapride: Cardiac events have been reported in patients receiving Fluconazole and Cisapride concomitantly. Co-administration of Cisapride is contraindicated in patients receiving Fluconazole. Cyclosporin: Concomitant administration of Fluconazole and Cyclosporin may result in increase in Cyclosporin concentrations. Oral Hypoglycaemic Agents: As Fluconazole is a potent inhibitor of CYP2C8 and CYP2C9, it may also interact with other sulphonylureas (eg.

Glimepiride and Gliclazide) and the thiazolidinediones (eg. Pioglitazone and Rosiglitazone), which are metabolised by these enzymes. When Fluconazole and sulphonylureas or thiazolidinediones are co-administered, blood glucose concentrations should be monitored carefully. The possibility of a hypoglycaemic episode should be borne in mind. Phenytoin: Concomitant administration of oral Fluconazole with Phenytoin at steady state levels resulted in an average increase of 75% of Phenytoin AUC values resulting in Phenytoin toxicity. Careful monitoring of Phenytoin concentrations in patients receiving Fluconazole and Phenytoin is recommended. Precautions: In rare cases, as with other azoles, anaphylaxis has been reported. AIDS patients are more prone to the development of serious cutaneous reactions to many drugs. Fluconazole should not be used again if a rash develops which is attributable to Fluconazole. Fluconazole has been associated with rare cases of serious hepatic toxicity including fatalities, primarily in patients with serious underlying medical conditions. Fluconazole should be administered with caution to patients with these potentially proarrhythmic conditions. Use in Pregnancy:Pregnancy Category D There are no adequate and wel-controlled studies in pregnant women hence should not be used. Use in Lactation: Fluconazole has been found in human breast milk at concentrations similar to plasma, hence its use in nursing mothers is not recommended. Presentation: SURFAZ-O is available in a blister strip of 1 tablet.

Hepatobiliary
Sorbiline Solution Stimuliv Syrup Stimuliv Tablets SORBILINE SOLUTION Composition: Each 10 ml. contains : Tricholine Citrate 0.55 g. Sorbitol Solution (70%) I.P. 7.15 g.

(Non-crystallizing) Sunset Yellow FCF (Colour Index 15985)

Description: SORBILINE contains Tricholine Citrate which is a salt of choline, an important lipotropic factor, deficiency of which leads to fatty infiltration of the liver. Fatty infiltration of the liver is present in several conditions e.g. diabetes mellitus, malnutrition, chronic alcoholism, etc. Tricholine Citrate can also be converted into methionine, an important amino acid in the human body. Sorbitol stimulates intestinal peristalsis, duodenal and pancreatic secretions and hence ameliorates dyspeptic symptoms. It also stimulates gall bladder contraction thus facilitating the entry of bile into the duodenum. SORBILINE acts as an ideal adjuvant to insulin in brittle diabetes. It smoothens the wide fluctuations of blood glucose levels and reduces insulin requirements. It reduces insulin antagonism by reducing blood levels of non-esterified fatty acids. Indications: Fatty infiltration of the liver which is common in malnutrition, malabsorption, chronic alcoholism, obesity and diabetes mellitus.

Hepatobiliary and digestive disorders such as biliary atonia or hypotonia, non obstructive biliary lithiasis, post hepatitis, chronic hepatic insufficiency, chronic pancreatic insufficiency.

Adjuvant in diabetes.

Atonic constipation.

Dosage: Disorders of the liver, gall bladder and digestive system : Adults : Two teaspoons with a little water at the beginning of lunch and / or dinner. Children : One to two teaspoons with a little water daily with lunch. Constipation :

Adults : Two to four teaspoons in a glass of water, in the morning before breakfast. Children : One to two teaspoons in a glass of water, in the morning before breakfast. Precautions:

1. It is not advisable to use SORBILINE alone in poorly controlled or 2. 3.

uncontrolled diabetes. It should always be used along with Insulin or Oral Hypoglycaemic Drugs in the management of diabetes. SORBILINE should be used with caution in the initial stages of viral hepatitis. SORBILINE should be avoided in obstructive jaundice.

Presentation: Bottles of 100 ml. and 200 ml.

STIMULIV SYRUP

Composition: Each 5 ml. contains water extracts of the following : Kalmegh 60 mg. Bhringaraj 100 mg. Pittapapda 100 mg. Bhui Amala 100 mg. Flavoured syrup base q.s. Description:

STIMULIV Syrup is a proprietary

ayurvedic preparation, containing a judicious combination of four timetested and clinically proven herbal medicines. Kalmegh is a cholagogue and an appetite stimulant. It also has antipyretic and anti-inflammatory properties. The active principle in Kalmegh is Kalmeghin. Bhringaraj contains large amount of resin and an alkaloid Ecliptine. Bhringaraj has anti-inflammatory properties and a mild purgative action. Its role as a hepatic and splenic decongestant is well-known. Pittapapda aids digestion and increases appetite. Together these three herbs increase bile secretion, reduce enlargement of the liver and spleen,

improve appetite and normalise the functions of the gastro-intestinal tract. Bhui Amala (a plant of the Genus Phyllanthus) has been widely used by traditional medical practitioners for the treatment of jaundice and other diseases. The extract of Bhui Amala is reported to inhibit the reaction between HBsAg (the surface antigen of the hepatitis B virus (HBV) and the antibody to it (anti-HBs). HBV contains an endogenous DNA polymerase which is required for its replication. Studies indicate that the extract of Bhui Amala also inhibits this endogenous DNA polymerase of HBV. Therefore STIMULIV Syrup is an ideal remedy for hepatic disorders of varied etiology. Moreover, STIMULIV Syrup is extremely palatable. Indications: Viral hepatitis. Toxic hepatitis including drug induced and alcoholic hepatitis. Loss of appetite. Indigestion. Dosage: Infants : 1/2 teaspoonful twice a day with milk or water. Children : 1/2 or 1 teaspoonful thrice a day with milk or water. Adults : 1 to 2 teaspoonfuls two or three times a day or as directed by the Physician. Packing:

STIMULIV Syrup is available in a bottle of 100 ml and 200 ml.

STIMULIV Tablets Composition: Each sugar coated tablet contains water extracts of : Kalmegh 50 mg. Bhringaraj 100 mg. Bhui Amala 200 mg. Katuki 100 mg. Guduchi 100 mg. Sarpunkha 100 mg. Kumari 100 mg. Nimba 100 mg. Chitrak 50 mg. Colour : Lake of sunset yellow FCF (Colour index No.15985)

Description:

STIMULIV Tablet is an ayurvedic formulation, which contains clinically

tested ayurvedic ingredients with hepato-protective functions.

STIMULIV Tablet contains nine

reviewed ingredients, which have hepatoprotective and decongestant action. Bhui Amala protects the liver from alcohol induced damage and the extract of Bhui Amala is reported to inhibit the reaction between HBsAg { the surface antigen of the hepatitis B virus (HBV) } and the antibody to it (anti-HBs). HBV contains an endogenous DNA polymerase, which is required for its replication. Studies indicate that the extract of Bhui Amala also inhibits this endogenous DNA polymerase of HBV. Bhringaraj is effective in cirrhosis and acts as a protective agent against hepatotoxic injury. Kumari, Kalmegh, Guduchi, and Chitrak are appetite stimulants and act as good purgatives. Sarpunkha is used to treat enlarged liver and spleen. Katuki and Nimba rectify problems of the stomach and promote a healthy digestive system. STIMULIV Tablet relieves intrahepatic biliary canalicular obstruction and improves bile drainage. It increases biliary secretion and stimulates gall bladder contraction. It also stimulates appetite and improves weight gain. STIMULIV Tablet stimulates peristalsis and relieves constipation. Therefore, STIMULIV Tablet is an ideal remedy for hepatic disorders of varied etiology. Indications: 1. For supportive therapy in viral hepatitis and toxic hepatitis including drug induced hepatitis and alcoholic hepatitis. 2. Loss of appetite, indigestion, constipation. 3. Liver and spleen enlargement. 4. Chronic cholecystitis. 5. Anorexia. Dosage: Adults : 1-2 tablets, 3 times a day. Children : As directed by the physician.

Presentation: Bottle of 60 sugar coated

STIMULIV tablets.

Antibiotic

BRAKKE TM Tablets
BRAKKETM Tablets Composition: Each film coated tablet contains : Ofloxacin U.S.P. 200 mg. Ornidazole 500 mg. Excipients q.s. Colour : Titanium Dioxide I.P. Description: Mixed aerobic and anaerobic infections are quite common in lower respiratory tract infections, diabetic foot infections, urinary tract infections, post surgical procedures, in acute diarrhoea and dysentery. Ofloxacin is one of the fluorinated quinolones with broad-spectrum coverage against gram-negative bacteria, gram-positive bacteria and also some anaerobes, whereas, Ornidazole is a 5-nitroimidazole derivative having broad-spectrum antimicrobial activity against gram-positive and gram-negative anaerobic bacteria and additionally broad-spectrum coverage against protozoas. Combining the two, results in a true broadspectrum activity, to treat systemic infections of mixed aerobic/anaerobic etiology, in all situations where the time is critical and laboratory investigations are not feasible. Indications: 1. Oral therapy of moderate to severe systemic infections with a probability of having mixed aerobic and anaerobic bacterial infections. In some cases, cephalosporins and/or aminoglycosides may be co-prescribed wherever necessary. These infections include : GI infections like appendicitis, cholecystitis. Post-operative infections after abdominal/gynaecological operations. Lung infections like bronchiectasis, lung abscess, empyema, etc. Acute or chronic bone and joint infections. Infections in patients with Diabetes Mellitus. Infections in immunocompromised patients. Oral follow-up of parenteral therapy with Ofloxacin and Ornidazole

or Tinidazole. 2. Acute diarrhoea or dysentery due to bacterial, protozoal or mixed causes. Dosage: Adults: 1 BRAKKE tablet twice daily after food for 5 days or as directed by the Physician. Contraindications: Known hypersensitivity to either ingredients. Severe renal insufficiency. Due to inadequate safety data, the drug should not be used during pregnancy, lactation and childhood, except where the risk to benefit ratio is justified.

Side Effects: The side effects of the tablet could be due to the individual ingredients. These include the following: Ornidazole Slight metallic taste, nausea, vomiting and gastrointestinal disturbances.

Urticaria, angioneurotic edema and other allergic states. Dizziness, drowsiness, headache, ataxia. Darkening of urine. Rare instances of relapse of epileptiform seizures.

Ofloxacin Mild gastrointestinal upsets. Rare cases of skin rashes, dizziness and headache. Precautions: Use with caution in mild to moderate renal failure, after appropriate dosage adjustment. Avoid alcohol during therapy and for two days after, in order to avoid risk of antabuse reaction. Ornidazole may augment the activity of oral anticoagulants, hence the dose of the latter may need reduction.

Presentation: BRAKKE tablets are available in strip of 10's. 10 such strips in a carton.

Exclusive Vitamins
NATVIETM C Capsules NATVIETM C Capsules

Composition: NATVIETM C 400

Each soft gelatin capsule contains: Vitamin E U.S.P. 400 I.U. (Equivalent to 268.4 mg of d-alpha tocopherol derived from natural vegetable oil). Vitamin C150 mg Approved colours used in capsule shell. NATVIETM C 200

Each soft gelatin capsule contains : Vitamin E U.S.P 200 I.U. (Equivalent to 134.2 mg of d-alpha tocopherol derived from natural vegetable oil). Vitamin C150 mg Approved colours used in capsule shell. NATVIETM C 100 Each soft gelatin capsule contains : Vitamin E U.S.P 100 I.U. (Equivalent to 67.1 mg of d-alpha tocopherol derived from natural vegetable oil). Vitamin C150 mg Approved colours used in capsule shell. Description: Cardiovascular disease (CVD) has assumed an epidemic proportion today across the globe. It has been estimated that CVD will emerge as a single largest contributor to mortality in India, accounting for nearly a third of all deaths. Oxidised LDL-C is a major responsible factor for atherosclerosis and related cardiovascular diseases. Recently many studies have proved that vitamin E prevents the LDL oxidation and thus reduces the risk of

atherosclerosis. NATVIE C provides pure Vitamin E in its natural form. Natural Vitamin E has 100% more activity in the body as compared to synthetic Vitamin E and it remains in the body for much longer period as compared to synthetic Vitamin E. Natural Vitamin E also activates certain genes and enzymes that protect against heart disease. Both Natural Vitamin E and Vitamin C are excellent antioxidant. They work synergistically in preventing oxidation of LDL-C as Vitamin C helps in revitalizing Vitamin E radicals. Both Vitamin E and Vitamin C reduce platelet aggregation and fibrinogenic activity, which explains their benefits in cardiovascular disease. Natural Vitamin E and Vitamin C work synergistically to: Improve blood circulation Prevent pre-eclampsia Prevent infertility Prevent inflammatory disorders Improve the neuromuscular and memory related disorders in elderly Reduce and prevent cardiovascular diseases

Indications : For slowing down the process of atherosclerosis As an adjuvant in ischemic heart disease/ myocardial infarction In the symptomatic management of leg cramps / and intermittent claudication Thrombotic CVA Supportive antiplatelet therapy, and in thrombotic tendencies causing circulatory insufficiencies e.g. IHD, peripheral vascular diseases, CVA, etc. Nutritional deficiency Cardiovascular disease in arthritis Pre-eclampsia Infertility Rheumatoid arthritis Supportive therapy in 'Geriatric' management

Dosage:

NATVIE C has been formulated to help maintain an optimum pro-circulatory dose of Natural Vitamin E at a level of 400 IU per day. NATVIE C 400 1 Capsule a day with food.

NATVIE C 200 1 Capsule twice a day with food. NATVIE C 100 2 capsules twice a day with food. Side effects or Adverse effects : May cause nausea and eruptions, particularly at higher doses. Vitamin E has antithrombotic activity and should be given with caution to patients with hemorrhagic disorder or those receiving anticoagulants or other drugs affecting coagulation. They should also be used with caution in asthmatic patients sensitive to aspirin. Contraindications: Hypersensitivity to any of the ingredients. Drug Interactions : May impair Vitamin K function at the level of prothrombin formation and thus potentiate the effect of Warfarin. Presentation: NATVIE C 400, NATVIE C 200 and NATVIE C 100 are available in blister packs of 10 soft gelatin capsules, such 3 blister strips in a carton.

Phytonutrient
MIXCAROTINTM Capsules Composition: Each soft gelatin capsule contains : Mixed carotenoids 15.44 mg (as oily suspension) (equivalent to 25,000 I.U. of Vitamin A.) Description: MIXCAROTIN is a judicious mixture of essential carotenoids : Alpha-carotene, Beta-carotene, Cryptoxanthin, Lutein and Zeaxanthin, all of them derived from natural source (sea algae Dunaliella salina). MIXCAROTIN is a judicious mix of essential phytonutrients (nutrients of plant source), closely resembling the ratio of essential phytonutrients present in a well-balanced mixed normal vegetarian diet, to which our body has learnt to depend on to safeguard itself for centuries. Phytonutrients are chemicals that the plants synthesize to protect

themselves from adverse chemicals, actinic radiation of the sun and environment. Our body can use them for similar protective purposes. Carotenoids are lipid soluble. MIXCAROTIN is an oily dispersion capsule to facilitate bio-availability. Following oral administration of MIXCAROTIN, the maximum concentration of all the carotenoids appear in chylomicrons after nine hours. MIXCAROTIN is a potent free radical scavenger to prevent oxidative stress and premature onset of senile degeneration of tissues caused by free radical damage. MIXCAROTIN suppresses lipid-peroxidation at endothelial structures to exhibit an anti-atherosclerotic effect, and thus reduces the risk of future chronic obstructive cardiovascular disorders like hypertension, ischemic heart disease, stroke, visual impairment and renal insufficiency. MIXCAROTIN not only promotes manufacture of light sensitive rhodopsin and iodopsin, but also filters harmful blue rays from damaging retinal structures, especially at the fovea to offer eye protection to prevent night-blindness and macular degeneration, respectively. MIXCAROTIN enhances cell mediated immunity in the geriatric population to offer additional immunological defense against common infections of the old age. * MIXCAROTIN has an independent role in obesity. * MIXCAROTIN prevents photosensitivity reactions. Indications: Prophylaxis against macular degeneration in persons with light coloured eyes (blue, hazel, green), outdoor workers, smokers, post-menopausal women and elderly. Prophylaxis against xerophthalmia, night blindness and defective colour vision in persons with compromised diet. Prophylaxis against atherosclerosis, especially in diabetes, obesity and hyperlipidemia. Prophylaxis against cancers arising from a wide variety of tissues. Maintenance of cell mediated immunity in old age. Prevention of photosensitivity reactions.

Dosage: One capsule daily or as advised by the Physician. Side Effects, Precautions and Contraindications: There are no side effects, contraindications or precautions specific to natural MIXCAROTIN. Presentation: MIXCAROTIN soft gelatin capsules are available in blister strip of 10's.

3 such strips in a carton.

BENEURON FORTE Tablets Composition: Each press coated tablet contains: Thiamine Propyl Disulphide 4.5 mg. Vitamin B2 I.P. 5.0 mg. Vitamin B6 I.P. 1.5 mg. Niacinamide I.P. 45.0 mg. Calcium Pantothenate I.P. 5.0 mg. Vitamin B12 I.P. 5.0 mcg. Folic Acid I.P. 1.0 mg. Vitamin C I.P. 75.0 mg. Adequate overages of Vitamins added to compensate for the loss on storage. Description: BENEURON FORTE is a combination containing Vitamin Bcomplex and Vitamin C in therapeutic doses. Vitamin B1 is in the form of Thiamine Propyl Disulphide, which is better absorbed, longer retained and hence better utilised than the conventional form of Vitamin B1. Since Vitamin B-complex and VitaminC cannot be stored in the body in high concentrations, deficiency of these vitamins is very common. Indications: Infections. Burns. Post operative and post traumatic conditions. Diabetes mellitus. Poor appetite. Dosage: Adults (for therapeutic use) : One tablet daily. Presentation: BENEURON FORTE is available in a strip of 10 tablets, 10 such strips in a carton. NATCARDINE Tablets Composition: Each uncoated tablet contains : Quinidine Phenylethylbarbiturate 0.1 g.

Erythrosine (colour index 45430) Description: NATCARDINE contains PHENYLETHYL barbiturate of QUINIDINE which has a therapeutic action superior to phenobarbitone and quinidine when given separately and it acts in a smaller dose. NATCARDINE is very well-tolerated and side effects like skin eruptions and gastrointestinal disturbances are rare. It reduces the excitability of the myocardium and depresses the vagal tone. It also prolongs the refractory period of heart muscles. These are the mechanisms by which it abolishes or prevents various cardiac arrhythmias. It also has a sedative action. Indications: A) Cardiology Atrial flutter Atrial fibrillation Paroxysmal supraventricular tachycardia Atrial and ventricular premature beats Cardiac Neurosis B) General Medicine Anxiety, irritability Palpitations Insomnia, temperamental instability Muscular cramps Dosage: Usually total daily dose of 1 to 3 tablets is sufficient. This can be given as tablet 3-4 times a day. The dose may be safely doubled if required, provided the patient is not showing any significant drowsiness which can interfere with day-to-day activity. NATCARDINE can safely be prescribed for long durations. In children, the dosage will vary according to age, from to 1 or 2 tablets per day. Contraindications: NATCARDINE is contra-indicated in complete and incomplete heart blocks. Side Effects: Side effects developing after long term administration of Quinidine salts (Cinchonism), are rarely seen in patients on NATCARDINE therapy as NATCARDINE is effective in much smaller doses as compared to conventional Quinidine salts. The acute side effects include G.I. intolerance and giddiness while symptoms of Cinchonism include tinnitus, bradycardia, slight blurring of vision and headache. Occasionally, a hypersensitivity reaction in the form of fever, is seen.

Anaphylactic shock is very rare. Drug interactions:

1. Nitroglycerine can cause postural hypotension in patients on

NATCARDINE.

2. NATCARDINE can cause increase in serum digoxin levels in those

taking both the drugs and the patients should be very carefully monitored. Presentation: NATCARDINE is available in a blister strip of 10 tablets, 5 such strips in a carton.

News & Happenings

Medical Science is growing at a very fast pace and is flooded with innovations and research findings. In the section ' News and Happenings ', Franco-Indian Pharmaceuticals Pvt. Ltd. brings to you from this plethora of information a few relevant and important findings of the recent past which could be of interest to you.

Gut Microbes Give Us Clues To Obesity Cause And Treatment

US scientists have discovered that "gut microbes" - bacteria that live in our digestive tract - could be powerful clues to the cause and treatment of obesity. This remarkable news was published in Nature this week and conducted at Washington University School of Medicine in St. Louis. The clue lies in the relative abundance of two major families of intestinal bacteria: Firmicutes and Bacteroidetes. These make up 90 per cent of the bacteria in the gut of humans, and, coincidentally, white mice. Researchers in the first of two parallel studies found that as obese people lose weight, the balance between the Firmicutes and the Bacteroidetes changes - the latter increasing in abundance as an overweight person gets slimmer. (It would seem that the microbes ending in "cute" are perhaps not as lovable as their name implies!). The second study was conducted in a neighbouring lab using white mice. Here, researchers discovered that the bacteria in the guts of obese white mice were more efficient at extracting calories from complex carbohydrates than the bacteria in the guts of slimmer mice. Also, in an earlier study, they had shown that the guts of obese mice had the same depletion of Bacteroidetes as found in the guts of the obese

humans. This means that you could have two guys eating the same amount of food (i.e. consuming the same calories) each day, and doing the same amount of exercise (i.e. burning equal number of calories) but over the course of several years, one gradually gets fatter and the other stays the same. Why? Because the one who stays the same has more Bacteroidetes in his gut, extracting fewer calories from the same amount of food. The poor guy who gets fatter has a more efficient calorie grabber in his gut, and the excess gets stored as fat - putting him at higher risk of eventually becoming obese. Trillions of "friendly" gut bacteria digest the food we eat by breaking down complex molecules like polysaccharides (complex carbs found in fruit, vegetables and grains) into simple sugars for energy. The excess is converted to fat for longer term storage. However, these studies suggest that the simple equation (calorie value of food intake) - (energy we use) equals (the fat we store), is different for different people. These studies form part of a growing body of research revealing fascinating new insights into what we are made of and what makes us tick. We used to think that the human body was a collection of cells with the same DNA imprint - like a unique bar code for each person. However, within us, in our guts, lie communities of microbes that outnumber our cells by 10 to 1, and, according to the researchers behind these two studies, "they may contain 100 times more genes than our own human genome". The researchers suggest that intestinal bacteria could become "biomarkers, mediators and potential therapeutic targets" in the fight against obesity.

Source: www.medicalnewstoday.com

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GENE CHIP DISCOVERY MAY LEAD TO INDIVIDUALIZED TREATMENT FOR FIVE HEREDITARY LIVER DISEASES Researchers at Cincinnati Children's Hospital Medical Center have developed the first gene chip to use in the early diagnosis of at least five hereditary liver diseases, to detect genetic causes of jaundice in children and adults, and potentially to lead to personalized treatment options. The chip, termed the "jaundice chip," is nearly 100 percent effective in the detection of the most common mutations in children with inherited causes of jaundice, according to a new Cincinnati Children's study in the

January issue of the journal Gastroenterology. "Other chips have been developed to assess drug metabolism," said Jorge Bezerra, MD, a pediatric gastroenterologist at Cincinnati Children's and the study's lead investigator. "This is the first chip in the world that has been customized to diagnose genetic mutations in patients with inherited types of liver diseases." The chip uses a new technology that rapidly and accurately discloses the composition of several genes known to cause liver disease in children and adults. "The jaundice chip may also help us to discover whether subtle changes in these five genes that can cause devastating diseases in children may also modify the clinical course of other common liver diseases in adults," said Mitchell Cohen, M.D., director of the division of gastroenterology hepatology and nutrition at Cincinnati Children's. Jaundice is a yellowing of the eyes and skin caused by impairment in bile flow from the liver to the intestine. Impaired bile flow, or cholestasis, commonly known as jaundice, can lead to severe liver disease. In children, jaundice and cirrhosis are responsible for more than half of the need for liver transplantation. Previous research on humans identified five genes responsible for inherited forms of jaundice. Until now, the broad array of causes of cholestasis including genetic, metabolic, inflammatory and drug- or toxin- induced disorders, created a challenge for physicians to diagnose a specific disease. Therefore, the treatment of affected children was not disease- specific and aimed at optimizing care to help reduce liver transplantation. With the jaundice chip, however, diagnosis can be simplified by surveying the genetic code for mutations in specific diseases. The jaundice chip was designed as a "five-in-one" gene chip to screen mutations (a permanent change in the DNA sequence that makes up a gene) in five genes using only one milliliter, or less than a half of a teaspoon, of blood. Gene chips contain several thousand small fragments of DNA on a small piece of glass. Incubation of these chips with the patient's DNA sample produce chemical signals that "glow" and allow for the detection of the normal gene sequence, or of mutations if they are present in the patient. "The jaundice chip is an extraordinary advance for our patients with liver diseases. It will improve diagnostic accuracy for perplexing diseases in infants and children, potentially decrease the need for invasive and costly studies, and allow us to develop specific treatment plans based on the correct genetic diagnosis," said Dr. Cohen. "With further genetic testing of liver disease, there is the potential that medications can be tailored to meet the needs of individual patients taking into account the patient's genetic make-up," adds Dr. Bezerra. "For now, the use of the gene chip gives families piece of mind, knowing what their child is living with. The next focus of advances will be the development of medication that may block progression of their disease.

Today, detection of liver diseases with the jaundice chip is continuing, using samples from children worldwide through a research protocol in the division of gastroenterology, hepatology and nutrition at Cincinnati Children's. Once approved by the Food and Drug Administration, the potential for wider use is limitless, according to Dr. Bezerra. The discovery of the jaundice chip was made possible through a grant from the Research Foundation at Cincinnati Children's with additional support by the National Institutes of Health (NIH).

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PHASE 2 CLINICAL TRIAL EVALUATES BREMELANOTIDE IN PRE- AND POST-MENOPAUSAL FEMALE SEXUAL DYSFUNCTION PATIENTS Palatin Technologies, Inc. (Amex: PTN) and King Pharmaceuticals, Inc. (NYSE: KG) announced that the companies have completed enrollment in the pre-menopausal cohort of a Phase 2 "at-home" clinical trial evaluating bremelanotide in pre- and post-menopausal patients experiencing female sexual dysfunction (FSD). The FSD clinical trial is designed to evaluate the initial multiple-dose safety and efficacy of bremelanotide in both pre- and post- menopausal women, and will provide the companies with information that will guide selection of clinical endpoints and estimates of treatment effect size for future clinical trials. The results from this trial are anticipated to be released in calendar year 2007. Bremelanotide is a drug candidate for the treatment of male and female sexual dysfunction and is being developed for regulatory approval and commercialization by Palatin and King Pharmaceuticals. "Based on positive results from a pilot safety/clinical pharmacology study evaluating bremelanotide in FSD patients, Palatin and King Pharmaceuticals are jointly committed to advancing the clinical development of bremelanotide for FSD and are pleased to report continued progress in the execution of our development program," said Trevor Hallam, Ph.D., Palatin's Executive Vice President of Research & Development. "Both female sexual dysfunction and male sexual dysfunction represent significant market opportunities where we believe bremelanotide has the potential to address unmet medical needs." About Female Sexual Dysfunction (FSD) FSD consists of four components, hypoactive sexual desire disorder, female sexual arousal disorder, dyspareunia or painful intercourse and anorgasmia. To establish a diagnosis of FSD, these components must be associated with personal distress, as determined by the affected woman.

A February 10, 1999 study published in the Journal of the American Medical Association, JAMA, titled, "Sexual Dysfunction in the United States: Prevalence and Predictors," states that some form of FSD appears to be prevalent in approximately 43 percent of the female population. About Bremelanotide (formerly PT-141) Bremelanotide is the first compound in a new drug class called melanocortin receptor agonists under development to treat sexual dysfunction. This new chemical entity is being evaluated in Phase 2 clinical trials studying the efficacy and safety profile of varying doses of this novel compound in men experiencing erectile dysfunction (ED) and women experiencing female sexual dysfunction (FSD). The mechanism of action of bremelanotide may offer important benefits over currently available products for the treatment of ED because it acts on the pathway that controls sexual function without acting directly on the vascular system. Clinical data indicates that bremelanotide may be effective in treating a broad range of patients suffering from ED. Although the current ED market is primarily served by PDE-5 inhibitors which target the vascular system, a substantial unmet medical need for alternative sexual dysfunction therapies exists. Many patients are contraindicated for, or non-responsive to, PDE-5 inhibitors. In addition, current literature indicates that about one half of all patients who receive an initial prescription for a PDE-5 inhibitor do not renew the prescription due chiefly to adverse side effects, drug interaction issues, and/or the lack of an acceptable level of responsiveness. About ED ED is defined as the consistent inability to attain and maintain an erection sufficient for sexual intercourse. The condition is correlated with increasing age, cardiovascular disease, hypertension, diabetes, hyperlipidemia and smoking. In addition, certain prescription drugs and psychogenic issues may contribute to ED. It is estimated that some degree of ED affects one half of all men over the age of 40 and that 150 million men worldwide suffer from ED.

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CYTOCHROME P450 VARIANT ASSOCIATED WITH FIRST TRIMESTER MISCARRIAGE

NEW YORK (Reuters Health) Dec 19 - Carriers of a polymorphism of the cytochrome P450 enzyme are at higher risk of miscarriage in the first trimester of pregnancy, Karolinska University investigators report in the November issue of Fertility and Sterility. The variant of cytochrome P450 1B1 (CYP1B1) is involved in the metabolism of androgens and estrogen, as well as theophylline, caffeine and other xenobiotics and some procarcinogens. CYP1B1 is expressed in the uterus, ovaries and breast. Dr. Anna-Helena Karypidis, and colleagues in Stockholm, conducted a population-based study of 507 women with first trimester miscarriages and 908 controls with normal first trimester pregnancies. All of the women were genotyped for the CYP1B1 polymorphism. Maternal age, smoking status, coffee and alcohol intake, fetal karyotype and nausea and vomiting were also assessed. Dr. Karypidis's team found an odds ratio of 1.46 for miscarriage among carriers of the CYP1B1 variant. Coffee drinkers who were homozygous carriers of the CYP1B1 polymorphism had a slightly higher risk than carriers who did not drink coffee during the first trimester. The increased risk with caffeine appeared to be nullified among smokers. The link between coffee consumption and miscarriage "might add to the understanding of the etiology of spontaneous abortions," Dr. Karypidis told Reuters Health. "However, before intervention studies are done, recommendations of diet restrictions based on genetic screening of CYP1B1 are premature," she cautioned. "If future intervention trials prove that caffeine restriction in those carrying the risk genotype will reduce their rate of spontaneous abortions, screening and diet guidance might be appropriate" at that time. "The enzyme CYP1B1 is present in the uterus and metabolizes both sex hormones and xenobiotics, including caffeine," she explained. "Caffeine is one of the most widely used xenobiotic compounds in the world and has earlier been linked to an increased risk of first trimester spontaneous abortion among heavy coffee drinkers." The investigators add that the variant "is rather common, and therefore its role in the mechanisms that lead to first trimester miscarriage may be clinically significant."

Source: www.medscape.com

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HBA1C EARLY IN DIABETIC PREGNANCY PREDICTS OUTCOMES NEW YORK (Reuters Health) Dec 15 - In women with diabetes, increasing hemoglobin A1c (HbA1c) levels in early pregnancy are associated with increasing risk of adverse pregnancy outcomes, according to a report in the December Diabetes Care. "Lowering of HbA1c seems to be associated with a reduced risk of adverse fetal outcome through a wider range of HbA1c values than previously thought," Dr. Gunnar L. Nielsen told Reuters Health. Dr. Nielsen and colleagues from Aalborg Hospital, Aarhus University Hospital, Aalborg, Denmark investigated the clinical utility of firsttrimester HbA1c level in predicting adverse outcomes in 537 pregnancies in women with type 1 diabetes. HbA1c levels averaged 7.4% in pregnancies with a good outcome, the team reports, compared with 8.5% in the 165 pregnancies that had an adverse outcome -- i.e., spontaneous or therapeutic abortion, stillbirth, neonatal death, or congenital anomaly. There was a consistently positive, almost linear association between increasing HbA1c levels and the risk of adverse pregnancy outcome beginning at an HbA1c level slightly below 7.0%, the results indicate. In a logistic regression model, each 1% increase in HbA1c corresponded to a 5.5% increase in risk of having an adverse outcome. However, HbA1c was not very helpful in predicting outcome of individual pregnancies. For example, 21% of pregnancies with HbA1c above 10% had a good outcome, while 15% of pregnancies with HbA1c less than 6% had an adverse outcome. "Although the association between HbA1c and outcome intuitively seems to be strong, it is obvious that other factors must be in play," Dr. Nielsen said. "This means that although we as physicians must stress the strong evidence for improved pregnancy outcome associated with lowering of HbA1c, we must still be aware that many pregnancies with high HbA1c values in fact end happily," Dr. Nielsen concluded. Source: Diabetes Care 2006;29:2612-2616.

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ADVANCES IN THE MANAGEMENT OF ANEMIA IN ONCOLOGY PRACTICE Although the erythropoiesis stimulating proteins (ESPs) recombinant erythropoietin and darbepoetin have become very important in the management of chemotherapy-induced anemia (CIA), reducing transfusion risk and fatigue levels, their uniform and universal integration

into routine oncology practice has been limited primarily by the resistance of CIA to ESP therapy. This has resulted in relatively high dose requirementscompared, for example to dialysis patientsand, even at high doses, a significant proportions of patients remaining unresponsive, fatigued and at risk for red cell transfusion. The net effect is that the cost effectiveness of ESPs in the management of CIA does not compare favorably to settings in which their value in anemia management is unquestioned. It has long been known that even normal subjects, when treated with ESPs, can evidence iron-restricted erythropoiesis, presumably due to rate limiting mobilization from storage iron, and may respond better to treatment with the addition of iron supplementation, particularly when administered parenterally. The recent discovery and characterization of the polypeptide hepcidin, the production of which by the liver is increased in inflammatory states including cancer and which has the effect of decreasing iron absorption from the gastrointestinal tract and inhibiting the mobilization of storage iron, has provided a framework for understanding the potential for parenteral iron to overcome the resistance to ESPs observed in patients with chronic illnesses such as cancer. In one randomized trial that has already been published, patients with CIA receiving epoetin alfa who received parenteral iron had an erythropoietic response that was significantly better than patients receiving epoetin alfa alone or with oral iron. This trial, while interesting, has been awaiting confirmation in subsequent trials. Vandebroek and colleagues presented an interim analysis of a very important trial. Patients with CIA were randomized (N=198) to receive darbepoetin alfa, 500 mcg every three weeks, with or without parenteral iron, 200 mg every three weeks.[8] For patients randomized to parenteral iron, a higher hemoglobin response rate was observed. More importantly, a lower risk of transfusion and a greater improvement in fatigue scores were observed in the parenteral iron group. These clinical outcomes have not been reported in previous CIA iron studies. If the interim data are indicative of the final conclusions of this study when complete, analyzed and published, this study will be an important one in guiding the way for improved erythropoietic management in oncology. Source :www.professional.cancerconsultants.com

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