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is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses including atopic dermatitis, contact dermatitis, eczematous dermatitis, neurodermatitis, seborrheic dermatitis, insect bites, lichen simplex chronicus, exfoliative dermatitis, stasis dermatitis, nummular eczema, psoriasis and pruritus ani and vulvae.

Corticosteroid, Glucocorticoids, Triamcinolone & Combined preparations

Triamcinolone Acetonide (a derivative of Triamcinolone) in a compatible base. Topical steroids are primarily effective because of their anti-inflammatory, antipruritic & vasoconstrictive actions.

A small amount of Triamcinolone is gently rub to the affected area 1-2 times daily. Some cases of eczematised psoriasis may be treated more effectively by the application of Triamcinolone under an occlusive dressing.

Occlusive dressing technique: Gently rub a small amount of Triamcinolone on the lesion until it disappears. Then reapply, leaving a thin coating and cover with a pliable non porous film. For convenience apply Triamcinolone intermittently (12 hour occlusion during the night) followed by reapplication without occlusion, during the day.

Pediatric use: Triamcinolone should not be used in children under 8 years. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children. As children are more likely to get side effects, they should not normally be treated for longer than 5 days.

The following local side effects have been reported with topical corticosteroids, either with or without occlusive dressings: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis and allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

Triamcinolone Acetonide is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. It is also contraindicated in tuberculosis of the skin, fungus infections and viral diseases of the skin (Herpes simplex, chickenpox and vaccinia), perioral dermatitis, rosacea and ulcerative conditions.

If reactions or idiosyncrasies are encountered, Triamcinolone Acetonide should be discontinued. The use of topical steroids on infected areas should be attended with caution and careful observation, bearing in mind the potential spreading of infections by anti-inflammatory steroids and the possible advisability of discontinuing steroid therapy and/or initiating antibacterial measures.

Triamcinolone Acetonide should not be used on healthy skin or over large areas of skin and not to be used in the eye as there is potential risk of glaucoma and cataract. When steroids are applied for long periods of time (more than 4 weeks) the occurrence of atrophic striae is likely. Prolonged use on flexures and intertriginous areas is undesirable. Children may absorb proportionately larger amounts of topical corticosteroids and thus may be more susceptible to systemic toxicity. In infants, long term continuous topical steroid therapy should be avoided. Adrenal suppression can occur even without occlusion.

There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroid should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether topical administration of corticosteroid could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects e.g., mild, reversible suppression of adrenal function, ecchymoses of the skin, peptic ulceration, hypertension, aggravation of infection, hirsutism, acne, edema and muscle weakness

Store in a cool & dry place. Protect from light.

Corticosteroid, Glucocorticoids, Triamcinolone & Combined preparations

The antiinflammatory actions of corticosteroids are thought to involve lipocortins, phospholipase A2 inhibitory proteins which, through inhibition of arachidonic acid, control the biosynthesis of prostaglandins and leukotrienes. Firstly, however, these glucocorticoids bind to the glucocorticoid receptors which translocate into the nucleus and bind DNA (GRE) and change genetic expression both positively and negatively. The immune system is suppressed by corticosteroids due to a decrease in the function of the lymphatic system, a reduction in immunoglobulin and complement concentrations, the precipitation of lymphocytopenia, and interference with antigen-antibody binding.

Adults and children over 12 years of age: Initial dose is 60 mg. Dosage is usually adjusted within the range of 40 to 80 mg. For local areas, dose for adults is up to 10 mg for smaller areas and up to 40 mg for larger areas.

Children 6 to 12 years: Initial dose is 40 mg

Cushingoid syndrome, weakness, bruising or purpura, aggravation of infections, peptic ulcer, activation of latent or aggravation of existing diabetes, altered menstrual cycle, hirsutism.

Triamcinolone Acetonide injection is contraindicated in patients with a sensitivity to the active or inactive ingredients.

Triamcinolone Acetonide injection should be used cautiously in patients with ocular herpes simplex, nonspecific ulcerative colitis, active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis, Cushing's syndrome, diabetes mellitus, congestive heart failure, chronic nephritis.

Aminoglutethimide: Aminoglutethimide may lead to a loss of corticosteroid-induced adrenal suppression. 

Amphotericin B injection and potassium-depleting agents: When corticosteroids are administered concomitantly with potassium-depleting agents (ie, amphotericin B, diuretics), patients should be observed closely for development of hypokalemia. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure. 

Antibiotics: Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance. 

Anticholinesterases: Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy.
 
Anticoagulants, oral: Coadministration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect.
 
Antidiabetics: Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required. 

Antitubercular drugs: Serum concentrations of isoniazid may be decreased. 

Cholestyramine: Cholestyramine may increase the clearance of corticosteroids. 

Cyclosporine: Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use. 

Digitalis glycosides: Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia. 
Estrogens, including oral contraceptives: Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect. 

Hepatic enzyme inducers (eg, barbiturates, phenytoin, carbamazepine, rifampin): Drugs which induce hepatic microsomal drug metabolizing enzyme activity may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. 

Ketoconazole: Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to an increased risk of corticosteroid side effects. 

Nonsteroidal anti-inflammatory drugs (NSAIDs): Concomitant use of aspirin (or other nonsteroidal anti-inflammatory drugs) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids. 

Skin tests: Corticosteroids may suppress reactions to skin tests. 

Vaccines: Patients on prolonged corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible.

Triamcinolone Acetonide injection should be used during pregnancy, nursing mothers if the possible benefits of the medication justify the potential hazards to the fetus or nursing infant.

Use in the elderly: The common adverse effects of systemic corticosteroids such as osteoporosis or hypertension may be associated with more serious consequences in old age. Close clinical supervision is recommended.

Use in children: As corticosteroids can suppress growth, the development of infants and children on prolonged corticosteroid therapy should be carefully observed. Caution should be taken in the event of exposure to chicken pox, measles or other communicable diseases. Children should not be vaccinated or immunized while on corticosteroid therapy. Corticosteroids may also affect endogenous steroid production.

Treatment of acute overdosage is by supportive and symptomatic therapy. For chronic overdosage in the face of severe disease requiring continuous steroid therapy, the dosage of the corticosteroid may be reduced only temporarily, or alternate day treatment may be introduced.

Store at controlled room temperature, 20-25°C, avoid freezing and protect from light.

This cream is indicated for the short-term treatment of moderate to severe melasma of the face, after starting the treatment avoid presence of sun. Use a sunscreen of at least SPF 30 or more.

Hydroquinone Preparations

This cream contains three active ingredients Fluocinolone Acetonide, Hydroquinone and Tretinoin. All of them are used to treat melasma. However, the mechanism of action of the active ingredients in This cream in the treatment of melasma is unknown but Fluocinolone Acetonide is a corticosteroid for topical dermatological use and is classified therapeutically as an anti-inflammatory. Hydroquinone is classified therapeutically as a depigmenting agent, which may interrupt one or more steps in the tyrosine-tyrosinase pathway of melanin synthesis. Tretinoin is classified therapeutically as a keratolytic agent.

This cream should be applied once daily at night. It should be applied at least 30 minutes before bedtime. Gently wash the face and neck with a mild cleanser. Rinse and pat the skin dry. Apply a thin film of the cream to the hyperpigmented areas of melasma including about ½ inch of normal-appearing skin surrounding each lesion. Rub lightly and uniformly into the skin. During the day, use sunscreen and wear protective clothing. Avoid sunlight exposure. Patients may use moisturizers and/or cosmetics during the day.

Pediatric Use: The safety and effectiveness of this cream in pediatric patients have not been established.

A very few patients may get severe allergic reactions from this cream. They may have trouble breathing or severe asthma attacks. While patients use this cream, skin may develop mild to moderate redness, peeling, burning, dryness or itching.

This cream is contraindicated in individuals with a history of hypersensitivity, allergy or intolerance to this product or any of its components.

This cream contains Hydroquinone and Tretinoin that may cause mild to moderate irritation. Local irritation, such as skin reddening, peeling, mild burning sensation, dryness and pruritus may be expected at the site of application. Transient skin reddening or mild burning sensation does not preclude treatment. If a reaction suggests hypersensitivity or chemical irritation, the use of the medication should be discontinued. This cream also contains the corticosteroid Fluocinolone Acetonide. Systemic absorption of topical corticosteroids can produce reversible Hypothalamic-Pituitary-Adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia and glucosuria can also be produced by systemic absorption of topical corticosteroid while on treatment. If HPA axis suppression is noted, the use of this cream should be discontinued. Recovery of HPA axis function generally occurs upon discontinuation of topical corticosteroids.

Avoid use of medicated or abrasive soaps, cleansers, soaps, cosmetics with drying effects, products with high concentration of alcohol, astringent & other irritants or keratolytic drugs. Also avoid concomitant use of medications with photosensitizing effects.

Pregnancy Category C. This cream contains the teratogen, tretinoin, which may cause embryo-fetal death, altered fetal growth, congenital malformations and potential neurologic deficits. It is difficult to interpret the animal studies on teratogenicity with this cream, because the availability of the dermal applications in these studies cannot be assured and comparison with clinical dosing is not possible. There are no adequate and well controlled studies in pregnant women. This cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation: Corticosteroids, when systemically administered, the drug appear in human milk. It is not known whether topical application of this cream could result in sufficient systemic absorption to produce detectable quantities of Fluocinolone Acetonide, Hydroquinone or Tretinoin in human milk. Because many drugs are secreted in human milk, caution should be exercised when this cream is administered to nursing women.

Store in a cool & dry place, protected from light. Do not freeze. Keep out of reach of children.

Trimetazidine Dihydrochloride is indicated in adults as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled by or intolerant to first-line antianginal therapies.

Other Anti-anginal & Anti-ischaemic drugs

Trimetazidine Dihydrochloride is the first 3- keto acyl CoA thiolase inhibitor (KAT), a metabolic anti-ischemic agent with proven benefits for all coronary patients. Trimetazidine Dihydrochloride inhibits fatty acid pathway by inhibiting 3-keto acyl CoA thiolase enzyme and transfers oxygen to glucose pathway. Since glucose pathway is more efficient in producing energy, the same oxygen produces more energy and makes the heart more active. Moreover, the aerobic oxidation of glucose stops production of lactic acid, which prevents angina pectoris.

The recommended dose of Trimetazidine is 35 mg twice daily or 20 mg tablet thrice daily during meals. The benefit of the treatment should be assessed after three months and Trimetazidine should be discontinued if there is no treatment response.

Trimetazidine is safe and well tolerated. The Common side effects associated with Trimetazidine are dizziness, headache, abdominal pain, diarrhoea, dyspepsia, nausea, vomiting, rash, pruritus, urticaria and asthenia

Trimetazidine is contraindicated in patients who have hypersensitivity to the active substance or to any of the excipients. It is also is contraindicated in patients with Parkinson’s disease, parkinsonian symptoms, tremors, restless legs movement disorders, severe renal impairment.

Trimetazidine is not a curative treatment for angina attacks, nor an initial treatment for unstable angina pectoris. It is also not a treatment for myocardial infarction.

No drug interaction so far has been reported. In particular, no interaction has been reported with beta-blockers, calcium antagonists, nitrates, heparin, hypolipidemic agents or digitalis preparation.

There is no data on the use of Trimetazidine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of Trimetazidine during pregnancy. It is unknown whether Trimetazidine is excreted in human milk. A risk to the newborns/infants cannot be excluded. Trimetazidine should not be used during breast-feeding.

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

Trimetazidine Dihydrochloride is indicated in adults as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled by or intolerant to first-line antianginal therapies.

Other Anti-anginal & Anti-ischaemic drugs

Trimetazidine Dihydrochloride is the first 3- keto acyl CoA thiolase inhibitor (KAT), a metabolic anti-ischemic agent with proven benefits for all coronary patients. Trimetazidine Dihydrochloride inhibits fatty acid pathway by inhibiting 3-keto acyl CoA thiolase enzyme and transfers oxygen to glucose pathway. Since glucose pathway is more efficient in producing energy, the same oxygen produces more energy and makes the heart more active. Moreover, the aerobic oxidation of glucose stops production of lactic acid, which prevents angina pectoris.

The recommended dose of Trimetazidine is 35 mg twice daily or 20 mg tablet thrice daily during meals. The benefit of the treatment should be assessed after three months and Trimetazidine should be discontinued if there is no treatment response.

Trimetazidine is safe and well tolerated. The Common side effects associated with Trimetazidine are dizziness, headache, abdominal pain, diarrhoea, dyspepsia, nausea, vomiting, rash, pruritus, urticaria and asthenia

Trimetazidine is contraindicated in patients who have hypersensitivity to the active substance or to any of the excipients. It is also is contraindicated in patients with Parkinson’s disease, parkinsonian symptoms, tremors, restless legs movement disorders, severe renal impairment.

Trimetazidine is not a curative treatment for angina attacks, nor an initial treatment for unstable angina pectoris. It is also not a treatment for myocardial infarction.

No drug interaction so far has been reported. In particular, no interaction has been reported with beta-blockers, calcium antagonists, nitrates, heparin, hypolipidemic agents or digitalis preparation.

There is no data on the use of Trimetazidine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of Trimetazidine during pregnancy. It is unknown whether Trimetazidine is excreted in human milk. A risk to the newborns/infants cannot be excluded. Trimetazidine should not be used during breast-feeding.

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

Treatment and relief of symptoms associated with irritable bowel syndrome (spastic colon). Postoperative paralytic ileus in order to accelerate the resumption of the intestinal transit following abdominal surgery.

Anticholinergics

Trimebutine maleate is a noncompetitive spasmolytic agent. It possesses moderate opiate receptor affinity and has marked anti-serotonin activity especially on 'mu' receptors. It induces regulation of spontaneous activity and increases synchronization between electrophysiological spikes and contractions in isolated guinea pig strips of colon and ileum. However, it does not alter normal motility, but regulates abnormal intestinal activity.

For adults: 100 mg to 200 mg, 3 times per day before meals.

Trimebutine maleate is generally well tolerated. The infrequently reported adverse effects are as follows: dry mouth, foul taste, diarrhea, dyspepsia, epigastric pain, nausea, constipation, drowsiness, fatigue, dizziness, hot/cold sensations, headache etc.

Patients with known hypersensitivity to trimebutine maleate or any excipient.

Elderly, pregnancy and lactation

Trimebutine maleate increases the duration of d-tubocurarine-induced curarization. No other druginteractions have been observed during clinical trial or otherwise reported.

Although teratological studies have not shown any drug related adverse effects on the course and outcome of pregnancy, the use of trimebutine maleate in pregnant women is not recommended.

It is not known if trimebutine maleate passes into breast milk. This medication should be used while breast feeding only if the potential benefits outweigh risks to the nursing infants.

No evidence of overdosage have been reported to date. However, if overdosage should occur following oral administration, gastric lavage is recommended. Treatment should be made according to the symptoms observed.

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

It is indicated for the relief of symptoms associated with seasonal & perennial allergic rhinitis. It is also indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria and allergen induced asthma.

Sedating Anti-histamine

Cetirizine Hydrochloride is a potent H1 receptor antagonist without any significant anticholinergic and antiserotonic effects. At pharmacologically active dose levels, it has almost no drowsiness effect and does not cause behavioral changes. It inhibits the histamine-mediated early phase of the allergic reaction and also reduces the migration of inflammatory cells and the release of mediators associated with the late phase of the allergic reaction.

Pharmacokinetics: Cetirizine 10 mg achieves peak plasma concentrations of 257 mcg/L within one hour of administration (980 mcg/L in children). Food does not affect the extent of absorption, but it may slightly reduce the rate. Peak blood levels 0.3 micrograms/ml are reached between thirty & sixty minutes after administration of 10 mg dose of Cetirizine. Its plasma half-life is approximately 11 hours. Absorption is very consistent from one subject to the next. Its renal clearance is 30 ml/minute and the excretion half-life is approximately nine hours.

Adults and Children 6 years and older: 1 tablet or 2 teaspoonfuls daily (or 1 teaspoonful twice daily).

Children 2-6 years: 1 teaspoonful once daily or 1/2 teaspoonful twice daily.

Children 6 months to 2 years : 1/2 teaspoonful once daily. The dose in children 12-23 months of age can be increased to a maximum dose as 1/2 teaspoonful every 12 hours.

The most common side effects that occurred more frequently on Cetirizine is somnolence.

It is contraindicated in patients with a history of hypersensitivity to Cetirizine or hydroxyzine.

Caution should be exercised when driving a car or operating a heavy machinery.

No clinically significant drug interactions have been found with Theophylline, Azithromycin, Pseudoephedrine, Ketoconazole or Erythromycin and with other drugs.

US FDA Pregnancy Category of Cetirizine Hydrochloride is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cetirizine Hydrochloride has been shown to be excreted in human milk. So, caution should be exercised when Cetirizine Hydrochloride is administered to a nursing woman.

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

It is indicated for the relief of symptoms associated with seasonal & perennial allergic rhinitis. It is also indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria and allergen induced asthma.

Sedating Anti-histamine

Cetirizine Hydrochloride is a potent H1 receptor antagonist without any significant anticholinergic and antiserotonic effects. At pharmacologically active dose levels, it has almost no drowsiness effect and does not cause behavioral changes. It inhibits the histamine-mediated early phase of the allergic reaction and also reduces the migration of inflammatory cells and the release of mediators associated with the late phase of the allergic reaction.

Pharmacokinetics: Cetirizine 10 mg achieves peak plasma concentrations of 257 mcg/L within one hour of administration (980 mcg/L in children). Food does not affect the extent of absorption, but it may slightly reduce the rate. Peak blood levels 0.3 micrograms/ml are reached between thirty & sixty minutes after administration of 10 mg dose of Cetirizine. Its plasma half-life is approximately 11 hours. Absorption is very consistent from one subject to the next. Its renal clearance is 30 ml/minute and the excretion half-life is approximately nine hours.

Adults and Children 6 years and older: 1 tablet or 2 teaspoonfuls daily (or 1 teaspoonful twice daily).

Children 2-6 years: 1 teaspoonful once daily or 1/2 teaspoonful twice daily.

Children 6 months to 2 years : 1/2 teaspoonful once daily. The dose in children 12-23 months of age can be increased to a maximum dose as 1/2 teaspoonful every 12 hours.

The most common side effects that occurred more frequently on Cetirizine is somnolence.

It is contraindicated in patients with a history of hypersensitivity to Cetirizine or hydroxyzine.

Caution should be exercised when driving a car or operating a heavy machinery.

No clinically significant drug interactions have been found with Theophylline, Azithromycin, Pseudoephedrine, Ketoconazole or Erythromycin and with other drugs.

US FDA Pregnancy Category of Cetirizine Hydrochloride is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cetirizine Hydrochloride has been shown to be excreted in human milk. So, caution should be exercised when Cetirizine Hydrochloride is administered to a nursing woman.

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

For topical application in the treatment of acne vulgaris in which comedones, papules and pustules predominate.

Topical retinoid and related preparations

Although the exact mode of action of Tretinoin is unknown, current evidence suggests that topical Tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedo formation. Additionally Tretinoin stimulates mitotic activity and increases turnover of follicular epithelial cells, causing extrusion of the comedones, papules and pustules.

This cream should be applied sparingly to the whole affected area once or twice daily. The skin should be thoroughly cleaned and dried before application. Patient should be advised that 6 to 8 weeks of treatment may be required before a therapeutic effect is observed. Moisturizers and cosmetics may be used during treatment with Tretinoin cream but should not be applied to the skin at the same time. Astringent toiletries should be avoided.

Initial external application of Tretinoin generally may cause burning or slight irritation, erythema and peeling at the site of application may also occur. If irritation becomes severe and persists, discontinue application and consult your physicians, if necessary.

Tretinoin is contraindicated to those who are highly sensitive to any of the ingredients. This cream should not be used in patients with a personal or family history of cutaneous epithelioma (skin cancer).

Avoid contact of Tretinoin with lips, mouth, eyes, eyelids, nostrils or another mucous membrane. If contact in these areas occurs, careful washing with water is recommended. Apply the cream to sensitive areas of skin, such as the neck, with caution. Do not use it on broken, eczematous or sun burned skin.

Other topical acne treatments should be used with caution during treatment with Tretinoin. Particular caution should be exercised when using preparation containing a peeling agent for example benzoyl peroxide. It is also possible to apply Tretinoin and benzoyl peroxide alternately. The suggested regimens are either Tretinoin in the morning and benzoyl peroxide in the evening or the preparations should be used on alternate days.

There is an inadequate evidence of the safety of topically applied Tretinoin in human pregnancy. Tretinoin has been associated with teratogenicity in human when administered systemically. So the cream should not be used during pregnancy and lactation.

Keep out of the reach of children. Keep in a cool & dry place, protect from light.

Third generation Cephalosporins

Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following

• ½-1 year: 75 mg daily.
• 1-4 years: 100 mg daily.
• 5-10 years: 200 mg daily.
• 11-12 years: 300 mg daily
• In typhoid fever, dosage should be 10 mg/kg/day for 14 days.

Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.

Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

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

Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.

Third generation Cephalosporins

Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following

• ½-1 year: 75 mg daily.
• 1-4 years: 100 mg daily.
• 5-10 years: 200 mg daily.
• 11-12 years: 300 mg daily
• In typhoid fever, dosage should be 10 mg/kg/day for 14 days.

Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.

Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

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

Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.

Third generation Cephalosporins

Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following

• ½-1 year: 75 mg daily.
• 1-4 years: 100 mg daily.
• 5-10 years: 200 mg daily.
• 11-12 years: 300 mg daily
• In typhoid fever, dosage should be 10 mg/kg/day for 14 days.

Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.

Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

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

Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.

Third generation Cephalosporins

Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following

• ½-1 year: 75 mg daily.
• 1-4 years: 100 mg daily.
• 5-10 years: 200 mg daily.
• 11-12 years: 300 mg daily
• In typhoid fever, dosage should be 10 mg/kg/day for 14 days.

Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.

Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

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

Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.

Third generation Cephalosporins

Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following

• ½-1 year: 75 mg daily.
• 1-4 years: 100 mg daily.
• 5-10 years: 200 mg daily.
• 11-12 years: 300 mg daily
• In typhoid fever, dosage should be 10 mg/kg/day for 14 days.

Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.

Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

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

Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.

Third generation Cephalosporins

Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following

• ½-1 year: 75 mg daily.
• 1-4 years: 100 mg daily.
• 5-10 years: 200 mg daily.
• 11-12 years: 300 mg daily
• In typhoid fever, dosage should be 10 mg/kg/day for 14 days.

Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.

Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

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

Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.

It is indicated in the following infections -

• Acute bacterial exacerbation of chronic bronchitis
• Acute community acquired pneumonia
• Pharyngitis or tonsillitis
• Skin and soft tissue infections
• Urinary tract infections
• Uncomplicated gonorrhea
• Acute maxillary sinusitis

Third generation Cephalosporins

Cefpodoxime is a third generation semi-synthetic Cephalosporin, exhibits activity against several Gram positive as well as Gram negative microorganisms. This compound is also stable in beta lactamase environment. Cefpodoxime exhibits exceptional activity against methicillin susceptible Staphylococci, Streptococcus pneumoniae, Haemophilus influenzae, Neisseria spp. and Moraxella catarrhalis.

Clavulanic acid is a natural inhibitor of beta lactamase which are produced by Streptomyces clavuligerus. It binds to beta lactamase moieties and inactivates them, thus restricting the Cefpodoxime destruction.

For adults (Age 12 years and older):

• Acute bacterial exacerbation of chronic bronchitis: 1 tablet 12 hourly for 10 days
• Acute community acquired pneumonia: 1 tablet 12 hourly for 14 days
• Pharyngitis or tonsillitis: ½ tablet 12 hourly for 5 to 10 days
• Skin and soft tissue infections: 2 tablet 12 hourly for 7 to 14 days
• Urinary tract infections: ½ tablet 12 hourly for 7 days
• Uncomplicated gonorrhea: Single dose
• Acute maxillary sinusitis: 1 tablet 12 hourly for 10 days

For children: Children 2 months to 12 years- 10 mg/kg/day in divided dose, every 12 hours.

Cefpodoxime is well tolerated. Most common gastrointestinal adverse effects are diarrhea, vomiting and abdominal pain.

Cefpodoxime is contraindicated in patients with known hypersensitivity to Cephalosporins.

Cefpodoxime should be administered with caution to patients receiving concurrent treatment with diuretics.

Concomitant administration of Cefpodoxime at high doses with antacids or H2 blockers reduces peak plasma levels of Cefpodoxime.

US FDA pregnancy category of Cefpodoxime & Clavulanic Acid is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefpodoxime have been shown to be excreted in human milk. So, caution should be exercised when Cefpodoxime is administered to a nursing woman.

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

This is indicated for the eradication of H. pylori in active chronic gastric, duodenal and gastric ulcers.

Anti H. pylori drugs

Lansoprazole is a proton-pump inhibitor which inhibits the stomach's production of gastric acids. Amoxicillin is a penicillin antibiotic. It acts by inhibiting the synthesis of bacterial cell walls.lt inhibits cross-linkage between the linear peptidoglycan polymer chains that make up a major component of the cell walls of both Gram-positive and Gram-negative bacteria. Clarithromycin is a macrolide antibiotic.It prevents bacteria from growing by interfering with their protein synthesis. It binds to the subunit 50S of the bacterial ribosome and thus inhibits the translation of peptides

Adult dose: One strip twice daily for 7-14 days or as per the physician's advice.

Geriatric use: Elderly patients may suffer from asymptomatic renal and hepatic dysfunction. Care should be taken when administering to these patients.

Adverse reactions which were reported as possibly or probably related to treatment (>3%) in clinical trials when all three components of this therapy were given concomitantly are listed below and divided by body systems. Digestive system: Nausea, vomiting, diarrhea, dark stools, dry mouth, glossitis, oral moniliasis, stomatitis, tongue discoloration. Musculoskeletal System: myalgia. Nervous System: confusion, headache, dizziness; Skin: skin reactions. Urogenital System: vaginitis,vaginal moniliasis.

This is contraindicated in patients with known hypersensitivity to any of its component.

Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on Amoxicillin therapy. These reactions are more appropriate to occur in individuals with a history of penicillin hypersensitivity. Clarithromycin should not be used in pregnant women except in clinical circumstances where no alternative therapy is appropriate.

There were no adequate and well-controlled studies  in pregnant women. This should be used during pregnancy only if the potential benefit justifies the potential risk of the mother. Amoxicillin is excreted in human milk in very small amounts. Because of the potential for serious adverse reactions in nursing infants. A decision should be made whether to discontinue nursing or to discontinue the drug therapy, taking into account the importance of the therapy to the mother.

Store in a cool and dry place, protected from light.

Drugs for HIV / Anti-retroviral drugs

Lamivudine, Zidovudine & Nevirapine synergistically reduce the viral resistance and inhibit reverse transcriptase via DNA chain termination.

Lamivudine: Intracellularly, Lamivudine is phosphorylated to its active 5’-triphosphate metabolite, Lamivudine triphosphate (L-TP). The principal mode of action of L-TP is inhibition of reverse transcription (RT) via DNA chain termination after incorporation of the nucleoside analogue. Following oral administration, Lamivudine is rapidly absorbed and extensively distributed. Binding to plasma protein is low.

Zidovudine: Intracellularly, Zidovudine is phosphorylated to its active 5’-triphosphate metabolite, Zidovudine triphosphate (ZDV-TP). The principal mode of action of ZDV-TP is inhibition of RT via DNA chain termination after incorporation of the nucleoside analogue. Following oral administration, Zidovudine is rapidly absorbed and extensively distributed. Binding to plasma protein is low. Zidovudine is eliminated primarily by hepatic metabolism.

Nevirapine: Nevirapine binds directly to reverse transcriptase (RT) and blocks the RNA-dependent and DNA-dependent DNA polymerase activities by causing a disruption of the enzyme's catalytic site. The activity of nevirapine does not compete with template or nucleoside triphosphates.

Adult dose: One tablet twice daily. This fixed dose combination is not recommended for patients who have not been on initial lower dose of Nevirapine 200 mg once daily for 2 weeks and /or have not tolerated this dose. After successful therapy with low dose Nevirapine for two weeks, patients can be switched over to 200 mg bid dose provided they have not demonstrated any hypersensitivity reaction (rash, abnormal liver function tests) during their initial exposure to Nevirapine. Monitoring of patients for their liver function tests etc. is desirable prior to initiating therapy with Nevirapine and monitoring at frequent intervals once therapy with fixed dose combination is continued.

Dosage adjustment:

• Lamivudine: For patients with low body weight (<50 kg) where dosage adjustment may be required, it is preferable not to use this fixed dose combination.
• Zidovudine: Because it is a fixed dose combination, this should not be prescribed for patients requiring dosage adjustment such as those with reduced renal function (creatinine clearance 50 ml/min) or those experiencing dose imiting adverse events.
• Nevirapine: For patients who experience severe rash or rash with constitutional complaints during the initial low dose Nevirapine phase of 14 days with once daily dose of 200 mg; neither, dose should be increased to twice daily nor they should receive triple fixed dose combination until the rash is resolved. Similarly for patients with abnormal liver function tests, Nevirapine therapy should be stopped till liver function return to normal and careful restart is advisable after extended observation. In event of recurrence, Nevirapine therapy can not be restarted.
• For patients where Nevirapine therapy has to be restarted after an interruption, daily dose of Nevirapine 200 mg for 14 days should be followed with twice daily dose in absence of any hypersensitivity reaction. Studies have not been documented to suggest dosage of Nevirapine in patients with hepatic dysfunction, renal insufficiency or undergoing dialysis.

Lamivudine: Pancreatitis, paresthesia, peripheral neuropathy, cough, dizziness, fatigue, gastrointestinal problems, headache, insomnia, anaemia, neutropenia, drug induced skin rash, hair loss.

Zidovudine: Headache (which may be severe, has been reported in up to 63% of patients receiving Zidovudine and asthenia has been reported in 9-69%), malaise and fatigue, fever or chills, nausea (61% cases), diaphoresis, dyspnoea, rash and taste perversion have been reported. Skin rashes and myalgia has been reported in patients receiving Zidovudine. Myopathy and myositis with pathologic changes similar to that produced by HIV infection, have been associated with prolonged use of Zidovudine. The major adverse effect is bone marrow toxicity resulting in severe anaemia and/or neutropenia. Patients with low serum folate or vitamin B12 concentrations may be at increased risk for developing bone marrow toxicity during Zidovudine therapy. There also are limited data suggesting that bone marrow of patients with fulminant acquired immunodeficiency syndrome (AIDS) may be more sensitive to Zidovudine induced toxicity than that of patients with less advanced disease (eg, AIDS related complex). Anaemia and granulocytopenia usually resolve when Zidovudine is discontinued or when dosage is decreased. Lactic acidosis (in the absence of hypoxaemia) and severe hepatomegaly with steatosis, including some fatalities, have been reported in patients receiving Zidovudine.

Nevirapine: More frequent incidences are skin rash, diarrhoea, gastrointestinal problems, headache, nausea and stomach pain. Incidence of less frequents are aphthous stomatitis, fever, hepatitis and Stevens Johnson syndrome.

History of hypersensitivity to Lamivudine, Zidovudine, Nevirapine and to any of the excipients available in formulation. Not to be used as initial therapy because initial therapy requires 200 mg once daily of Nevirapine whereas fixed dose combination allows for 200 mg twice daily of Nevirapine.

For the following conditions, assess risk to patient and take action as needed, chronic hepatitis B, hepatomegaly with steatosis, lactic acidosis, liver function impairment, severe renal function impairment, peripheral neuropathy.

Zidovudine: acyclovir and valacyclovir may increase CNS depression. Increased risk of haematologic toxicity with ganciclovir, valganciclovir, dapsone, doxorubicin, vincristine and vinblastine. Doxorubicin may reduce phophorylation; fluconazole may increase levels/effects; increased risk of hepatic decompensation or haematologic toxicities with interferon and ribavirin (also increases risk of pancreatitis and lactic acidosis). Methadone may increase effects/levels. Increased risk of myalgia, malaise and/or fever, maculopapular rash and effects/levels with probenecid. Stavudine may decrease antiviral activity; valproic acid may increase plasma levels (AUC increased by 80%).

Lamivudine: Increased risk of hepatic decompensation or haematologic toxicities with interferon and ribavirin (also increases risk of mitochondrial toxicity, pancreatitis and lactic acidosis). Ganciclovir and valganciclovir may increase effects and toxicity; sulfamethoxazole/ trimethoprim may increase AUC and decrease clearance (increasing levels and effects).

Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks

Should be stored in cool and dry place

Triamcinolone & Combined preparations

Adults: This cream should be applied sparingly to the skin lesion no more than 2 times daily, preferably once in the morning and once in the evening. This cream should not be applied with an occlusive dressing, or to large areas of skin on the body. The duration of treatment with this cream should continue until the inflammatory symptoms subside but not longer than 2 weeks; after 2 weeks of therapy with this cream, continue therapy as needed with a preparation containing econazole or econazole nitrate alone.

Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight. Caution should be exercised.

Rarely, transient local mild irritation, itching & redness may occur immediately after application. Econazole has the minimal allergenic effect and is well tolerated, even by delicate skin. Adrenal suppression on long term continuous topical steroid therapy may occur, particularly in infants or children, or when occlusive dressings are applied. It should be noted that an infant's napkin may act as an occlusive dressing.

This Cream is contraindicated-

• In individuals who have shown hypersensitivity to any of its ingredients.
• Like any other dermatological preparation containing corticosteroids, this Cream is contraindicated in specific skin conditions such as tuberculous, varicella, herpes simplex or other viral infections of the skin, or fresh vaccination sites.
• Decubitus ulcers: Viral, bacterial or fungal skin infections (e.g. tuberculosis of the skin, syphilis of the skin, herpes simplex, herpes zoster, chickenpox).
• Rosacea and rosacea-like dermatitis.

• For external use only. This Cream is not for ophthalmic or oral use.
• If a reaction suggesting hypersensitivity or chemical irritation should occur, use of the medication should be discontinued.
• Corticosteroids applied to the skin can be absorbed in sufficient amounts to produce systemic effects, including adrenal suppression. Systemic absorption may be increased by various factors such as application over a large skin surface area, application to damaged skin, application under occlusive skin dressings and prolonged duration of therapy.
• Topical corticosteroids are associated with skin thinning and atrophy, striae, telangiectasis and purpura.
• Topical corticosteroids may lead to increased risk of dermatological superinfection or opportunistic infection.

Children: Increased caution is required when treating children. Compared to adults, the nature of a child's skin and the larger skin surface area relative to body weight may lead to an increased absorption of the corticosteroid via the child's skin. This cream should be used in children only for short periods of time (less than 2 weeks) and on small areas (less than 10% of body surface area).

Visual disturbance may be associated with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR).

Econazole: compound metabolized by CYP3A4/2C9 oral anticoagulants (warfarin & acenocoumarol).

Triamcinolone: lowering of plasma salicylates levels. Increased risk of Gl bleeding and ulceration with NSAIDs. Antagonised blood glucose-lowering effects of the antidiabetics. Increased risk of Hyperkalemia with amphotericin B, beta-blockers, potassium-depleting diuretics, theophylline. Increased clearance of the triamcinolone with ciclosporin, carbamazepine, phenytoin, barbiturate, rifampicin.

Pregnancy: Not the Econazole but the Triamcinolone Acetonide crosses the placenta and topical administration of corticosteroids during pregnancy can cause abnormalities of foetal development. The relevance of this finding to human beings has not been established. However, topical steroids in large amounts or for prolonged periods
should not be used in pregnancy.

Lactation: Negligible amount of econazole and to some extent Triamcinolone may be excreted in small amounts in breast milk. So this cream should not be prescribed to the lactating mother or if prescribed lactation should be withheld during treatment.

This Cream is for cutaneous application only. Corticosteroids applied to the skin, including triamcinolone, can be absorbed in sufficient amounts to produce systemic effects. In the event of accidental ingestion, treat symptomatically. If this cream is accidentally applied to the eyes, wash with clean water or saline and seek medical attention if symptoms persist.

Store in a cool (below 30°C) and dry place, away from light. Keep out of the reach of children.

Amitriptyline Hydrochloride is indicated in-

• Depressive Illness: particularly where sedation is required.
• Nocturnal Enuresis in children.
• Prophylaxis of Migraine.
• Tension Headache.
• Chronic Pain.

Tricyclic Anti-depressant

The mechanism of action of this drug is not fully elucidated. It is suggested that amitriptyline inhibits the membrane pump mechanism responsible for the re-uptake of transmitter amines, such as norepinephrine and serotonin, thereby increasing their concentration at the synaptic clefts of the brain. These amines are important in regulating mood. The monoamine hypothesis in depression, one of the oldest hypotheses, postulates that deficiencies of serotonin (5-HT) and/or norepinephrine (NE) neurotransmission in the brain lead to depressive effects. This drug counteracts these mechanisms, and this may be the mechanism of amitriptyline in improving depressive symptoms. Whether its analgesic effects are related to its mood-altering activities or attributable to a different, less obvious pharmacological action (or a combination of both) is unknown.

Depression: Initially 75 mg (Elderly and Adolescents 30-75 mg) daily in divided doses or as a single dose at bedtime increased gradually as necessary to 150-200 mg; Child under 16 years not recommended for depression.

Nocturnal Enuresis: Child 7-10 years: 10-20 mg, 11-16 years: 25-50 mg at night; max. period of treatment (including gradual withdrawal) 3 months-full physical examination before the further course.

Prophylaxis of Migraine: 100 mg daily.

Tension Headache: 10-25 mg three times daily.

Amitriptyline is contraindicated in myocardial infarction, arrythmias, particularly heart block of any degree, mania and severe liver disease. Initially, sedation may affect the ability to drive or operate machinery.

It should be used with caution in patients with a history of epilepsy, glaucoma, urinary retention, cardiac disease, diabetes, pregnancy, hepatic impairment, thyroid disease, increased intra-ocular pressure and psychoses (may aggravate mania).

TCA enhances the sedative effect of alcohol and opioid analgesics. When TCA is used with Moxifloxacin or Terfenadine, it increases the risk of ventricular arrhythmias. Disulfirum and Cimetidine inhibit the metabolism of Amitriptyline. When TCA is used with diuretics, it enhances the risk of postural hypotension.

Pregnancy Category C. Amitriptyline has been shown to cross the placenta. Amitriptyline should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. Amitriptyline is excreted into breast milk. Because of the potential for serious adverse reactions in nursing infants from Amitriptyline, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Store in a cool and dry place, below 30°C. Protect from light and moisture.