Find Medicines

This is indicated for the treatment and prophylaxis of Iron, Folic Acid and Zinc deficiency especially during pregnancy and lactation.

Iron, Vitamin & Mineral Combined preparation

Adult or Elderly: 1 capsule daily. In more severe cases, 2 capsules daily may be required.

Children: Aged over 1 year: 1 capsule daily. The capsule may be opened and the pellets to be mixed with soft cool food, but they must not be chewed.

Dark stools are usual during iron therapy and nausea and other symptoms of gastrointestinal irritation such as anorexia, vomiting, discomfort, constipation and diarrhoea are sometimes encountered. Zinc may also produce a gastrointestinal upset. These timed-release capsules are designed to reduce the possibility of gastrointestinal irritation. There have been rare reports of allergic reactions

Do not use in patients hypersensitive to the components of the product or those with iron overload.

Care should be taken in patients who may develop Iron overloads, such as those with haemochromatosis, haemolytic anaemia or red cell aplasia. Failure to respond to treatment may indicate other causes of anaemia and should be further investigated. Iron & Zinc chelate with tetracycline and absorption of all three agents may be impaired. The absorption of Zinc may be reduced in the presence of Iron. Absorption of Iron may be impaired by penicillamine and by antacids. Such potential interactions can be reduced by separating the administration of each product by several hours. In patients with renal failure a risk of Zinc accumulation could exist.

Use of any drug during the first trimester of pregnancy should be avoided if possible. Thus administration of Iron during the first trimester requires definite evidence of Iron deficiency where inadequate diet calls for supplementary Zinc and Folic acid is justified during the remainder of the pregnancy.

Iron overdosage is dangerous, particularly in children and requires immediate attention. Gastric lavage should be carried out in the early stages, or if this is not possible vomiting should be induced. These procedures should not be undertaken where signs of the corrosive effects of zinc are present. Give oral desferrioxamine (2 gm for a child or 5 gm for an adult) and demulcent. If serum Iron levels at 4 hours or more post-ingestion are over 5mg/l in a child or 8 mg/l in adults, or if the patient is in shock of coma, intravenous desferrioxamine should be used. Zinc Sulphate in gross over dosage is corrosive. Symptoms are those of gastrointestinal irritation leading in severe cases to haemorrhage, corrosion of the mucosa and possible later stricture formation. Gastric lavage or emesis should be avoided. Demulcents such as milk should be given. Chelating agents such as Dimercaprol, Penicillamine or Edetic Acid have been recommended.

Symptomatic and supportive measures should be given as required. The timed-release capsule presentation may delay excessive absorption of Iron and Zinc and allow more time for initiation of appropriate counter-measure.

Protected from light and moisture, store below 30˚C. Keep out of reach of children.

Ephedrine is indicated to reverse hypotension induced by spinal or epidural anaesthesia. It is of little value in hypotensive crisis due to shock, circulatory collapse, or haemorrhage.

Other adrenoceptor stimulants, Vasoconstrictor/Venotonic

Ephedrine is a stimulant drug, belonging to a group of medicines known as sympathomimetics. Specifically it is both an alpha and beta adrenergic agonist. In addition, Ephedrine enhances the release of norepinephrine, a strong endogenous alpha agonist. The action of this compound is notably similar to that of the body's primary adrenergic hormone epinephrine (adrenaline), which also exhibits action toward both alpha and beta receptors. When administered, Ephedrine will notably increase the activity of the central nervous system, as well as have a stimulatory effect on other target cells.

To reverse hypotension induced by spinal or epidural anaesthesia 3 to 6 mg (or at most 9 mg) Ephedrine Hydrochloride is given by slow intravenous injection and repeated every 3 to 4 minutes as required; the maximum total dose is 30 mg. Ephedrine has also been given by intramuscular or subcutaneous injection.

Adverse effects reported are nausea, vomiting, anorexia; tachycardia (sometimes bradycardia), arrhythmias, anginal pain, vasoconstriction with hypertension, vasodilation with hypotension, dizziness and flushing; dyspnoea; headache, anxiety, restlessness, confusion, psychoses, insomnia, tremor; difficulty in micturition, urine retention; sweating, hypersalivation; changes in blood-glucose concentration; very rarely angle-closure glaucoma.

The use of Ephedrine is contraindicated in the presence of coronary thrombosis. It should be used with caution in patients with organic heart disease, cardiac decompensation, hyperthyroidism, hypertension, and angina pectoris, and in patients receiving digitalis.

Ephedrine should be given with care to patients with hyperthyroidism, diabetes mellitus, ischemic heart disease, hypertension, renal impairment, or angle-close glaucoma. In patients with prostatic enlargement, Ephedrine may increase difficulty with micturition. Use in pregnancy and lactation: Increased fetal heart rate reported with parenteral Ephedrine. Irritability and disturbed sleep have been reported in breast-fed infants.

Administration of Ephedrine may cause a hypertensive crisis in patients receiving an Monoamine Oxidase Inhibitor (including an Reversible Inhibitor of Monoamine Oxidase type A). Ephedrine should be avoided or used with care in patients undergoing anaesthesia with cyclopropane, halothane, or other volatile anaesthetics. An increased risk of arrhythmias may occur if given to patients receiving cardiac glycosides, quinidine, or tricyclic antidepressants, and there is an increased risk of vasoconstrictor or pressor effects in patients receiving ergot alkaloids or oxytocin

Pregnancy: Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Lactation: Ephedrine Hydrochloride is distributed into breast milk, and therefore Ephedrine Hydrochloride Injection is not recommended for use during lactation because of the risk of adverse effects in the infant.

When given in sufficiently large doses Ephedrine gives rise in most patients to certain minor reactions, such as giddiness, headache, nausea, vomiting, sweating, palpitations, difficulty in micturition, tremors, anxiety, restlessness and insomnia; some patients may exhibit these symptoms even with the usual therapeutic dosage.

Store in a cool, dry place, protected from light. Keep all medicines out of reach of children.

This is indicated for the treatment and prophylaxis of Iron, Folic Acid and Zinc deficiency especially during pregnancy and lactation.

Iron, Vitamin & Mineral Combined preparation

Adult or Elderly: 1 capsule daily. In more severe cases, 2 capsules daily may be required.

Children: Aged over 1 year: 1 capsule daily. The capsule may be opened and the pellets to be mixed with soft cool food, but they must not be chewed.

Dark stools are usual during iron therapy and nausea and other symptoms of gastrointestinal irritation such as anorexia, vomiting, discomfort, constipation and diarrhoea are sometimes encountered. Zinc may also produce a gastrointestinal upset. These timed-release capsules are designed to reduce the possibility of gastrointestinal irritation. There have been rare reports of allergic reactions

Do not use in patients hypersensitive to the components of the product or those with iron overload.

Care should be taken in patients who may develop Iron overloads, such as those with haemochromatosis, haemolytic anaemia or red cell aplasia. Failure to respond to treatment may indicate other causes of anaemia and should be further investigated. Iron & Zinc chelate with tetracycline and absorption of all three agents may be impaired. The absorption of Zinc may be reduced in the presence of Iron. Absorption of Iron may be impaired by penicillamine and by antacids. Such potential interactions can be reduced by separating the administration of each product by several hours. In patients with renal failure a risk of Zinc accumulation could exist.

Use of any drug during the first trimester of pregnancy should be avoided if possible. Thus administration of Iron during the first trimester requires definite evidence of Iron deficiency where inadequate diet calls for supplementary Zinc and Folic acid is justified during the remainder of the pregnancy.

Iron overdosage is dangerous, particularly in children and requires immediate attention. Gastric lavage should be carried out in the early stages, or if this is not possible vomiting should be induced. These procedures should not be undertaken where signs of the corrosive effects of zinc are present. Give oral desferrioxamine (2 gm for a child or 5 gm for an adult) and demulcent. If serum Iron levels at 4 hours or more post-ingestion are over 5mg/l in a child or 8 mg/l in adults, or if the patient is in shock of coma, intravenous desferrioxamine should be used. Zinc Sulphate in gross over dosage is corrosive. Symptoms are those of gastrointestinal irritation leading in severe cases to haemorrhage, corrosion of the mucosa and possible later stricture formation. Gastric lavage or emesis should be avoided. Demulcents such as milk should be given. Chelating agents such as Dimercaprol, Penicillamine or Edetic Acid have been recommended.

Symptomatic and supportive measures should be given as required. The timed-release capsule presentation may delay excessive absorption of Iron and Zinc and allow more time for initiation of appropriate counter-measure.

Protected from light and moisture, store below 30˚C. Keep out of reach of children.

This is a combination of lactic acid, citric acid, and potassium bitartrate indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.

Miscellaneous topical agents

The combination of lactic acid, citric acid, and potassium bitartrate comes as a gel in a pre-filled applicator to be applied into the vagina. It is usually applied into the vagina immediately before (up to one hour) before each act of vaginal intercourse. If more than one act of vaginal intercourse occurs within one hour, apply another dose into the vagina. Do not apply more or less of it or apply it more often than prescribed by your doctor.

Lactic acid, citric acid, and potassium bitartrate vaginal gel may be used at any time during the menstrual cycle. It may be used with hormonal contraceptives (birth control pills, patches, or implants); latex, polyurethane and polyisoprene condoms; or a vaginal diaphragm. Do not use this medication along with a contraceptive vaginal ring. Lactic acid, citric acid, and potassium bitartrate vaginal gel may be applied after your doctor has told you that it is safe to resume vaginal intercourse after childbirth, abortion, or miscarriage.

To use the lactic acid, citric acid, and potassium bitartrate vaginal gel, follow these steps:

• Wash your hands with soap and water before opening the foil pouch.
• Remove the pre-filled applicator and plunger rod from the foil pouch.
• Slowly insert the plunger rod into the pre-filled applicator. Push until you feel the tip of the plunger rod connect to the inside of the pre-filled applicator.
• Do not push hard or continue to push after the tip of the plunger rod connects to the inside of the pre-filled applicator as it could cause the gel to go into the pink cap. Use a new pre-filled applicator if the gel enters the pink cap.
• After the plunger rod is connected to the pre-filled applicator, remove the pink cap from the pre-filled applicator. The extra space between the gel and the end of the pre-filled applicator is normal.
• Hold the pre-filled applicator at the grooved area closest to the plunger rod. Gently insert the pre-filled applicator into the vagina as far as it will comfortably go while you continue to hold the plunger rod. You can do this while sitting with your knees apart, lying on your back with your knees bent, or while standing with your feet apart or knees bent.
• While the pre-filled applicator is inserted in your vagina, use your index finger to push the plunger rod down until it stops to ensure that you receive the entire dose. It is normal for a small amount of gel to be left in the applicator.
• Gently remove the plunger rod and pre-filled applicator from the vagina. Discard the used pre-filled applicator and cap in the trash.

Most common adverse reactions (≥2%) were vulvovaginal burning sensation, vulvovaginal pruritus, vulvovaginal mycotic infection, urinary tract infection, vulvovaginal discomfort, bacterial vaginosis, vaginal discharge, genital discomfort, dysuria, and vulvovaginal pain.

Before using lactic acid, citric acid, and potassium bitartrate vaginal,

• tell your doctor and pharmacist if you or your sexual partner are allergic to lactic acid, citric acid, and potassium bitartrate, any other medications, or any of the ingredients in lactic acid, citric acid, and potassium bitartrate vaginal gel. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take or use. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or had urinary tract infections or problems with urination.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using lactic acid, citric acid, and potassium bitartrate vaginal, call your doctor.

There is no use in pregnancy; therefore, discontinue this during pregnancy. There are no data on the presence of lactic acid, citric acid, and potassium bitartrate or their metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.

Pediatric Use: The safety and effectiveness of this gel have been established in females of reproductive potential. Efficacy is expected to be the same for post-menarchal females under the age of 17 as for users 17 years and older. The use of this gel before menarche is not indicated.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture

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.

This is indicated for the treatment and prophylaxis of Iron, Folic Acid and Zinc deficiency especially during pregnancy and lactation.

Iron, Vitamin & Mineral Combined preparation

Adult or Elderly: 1 capsule daily. In more severe cases, 2 capsules daily may be required.

Children: Aged over 1 year: 1 capsule daily. The capsule may be opened and the pellets to be mixed with soft cool food, but they must not be chewed.

Dark stools are usual during iron therapy and nausea and other symptoms of gastrointestinal irritation such as anorexia, vomiting, discomfort, constipation and diarrhoea are sometimes encountered. Zinc may also produce a gastrointestinal upset. These timed-release capsules are designed to reduce the possibility of gastrointestinal irritation. There have been rare reports of allergic reactions

Do not use in patients hypersensitive to the components of the product or those with iron overload.

Care should be taken in patients who may develop Iron overloads, such as those with haemochromatosis, haemolytic anaemia or red cell aplasia. Failure to respond to treatment may indicate other causes of anaemia and should be further investigated. Iron & Zinc chelate with tetracycline and absorption of all three agents may be impaired. The absorption of Zinc may be reduced in the presence of Iron. Absorption of Iron may be impaired by penicillamine and by antacids. Such potential interactions can be reduced by separating the administration of each product by several hours. In patients with renal failure a risk of Zinc accumulation could exist.

Use of any drug during the first trimester of pregnancy should be avoided if possible. Thus administration of Iron during the first trimester requires definite evidence of Iron deficiency where inadequate diet calls for supplementary Zinc and Folic acid is justified during the remainder of the pregnancy.

Iron overdosage is dangerous, particularly in children and requires immediate attention. Gastric lavage should be carried out in the early stages, or if this is not possible vomiting should be induced. These procedures should not be undertaken where signs of the corrosive effects of zinc are present. Give oral desferrioxamine (2 gm for a child or 5 gm for an adult) and demulcent. If serum Iron levels at 4 hours or more post-ingestion are over 5mg/l in a child or 8 mg/l in adults, or if the patient is in shock of coma, intravenous desferrioxamine should be used. Zinc Sulphate in gross over dosage is corrosive. Symptoms are those of gastrointestinal irritation leading in severe cases to haemorrhage, corrosion of the mucosa and possible later stricture formation. Gastric lavage or emesis should be avoided. Demulcents such as milk should be given. Chelating agents such as Dimercaprol, Penicillamine or Edetic Acid have been recommended.

Symptomatic and supportive measures should be given as required. The timed-release capsule presentation may delay excessive absorption of Iron and Zinc and allow more time for initiation of appropriate counter-measure.

Protected from light and moisture, store below 30˚C. Keep out of reach of children.

This is indicated for the treatment and prophylaxis of Iron, Folic acid, Vitamin B complex and Vitamin C deficiency, or to meet extra need of these vitamins and minerals especially in pregnancy or when planning for pregnancy.

Iron & Vitamin Combined preparations

Iron is an essential mineral, with several important roles in the body. For example, it helps to make red blood cells, which carry oxygen around the body. A lack of iron can lead to iron deficiency anaemia. Liver is a good source of iron, don't eat it if you are pregnant. This is because it is also rich in vitamin A which, in large amounts, can harm your unborn baby.

Folic acid is essential for the production of certain coenzymes in many metabolic systems such as purine and pyrimidine synthesis. It is also essential in the synthesis and maintenance of nucleoprotein in erythropoesis. It also promotes WBC and platelet production in folate-deficiency anaemia.

Vitamin C is necessary for collagen formation and tissue repair; plays a role in oxidation/reduction reactions as well as other metabolic pathways including synthesis of catecholamines, carnitine, and steroids; also plays a role in conversion of folic acid to folinic acid.

Vitamin B complex: The building blocks for good health come from a variety of foods, even if they are from the same family of nutrients. Such is the case with vitamin B, a key player in maintaining cell health and keeping you energized.

Not all types of vitamin B do the same thing. Additionally, the different types of vitamin B all come from different types of foods.

Vitamin B deficiencies can lead to health problems. Sometimes a doctor will prescribe a supplement when they think you’re not getting enough.

Recommended adult dose is one capsule daily. In more severe deficiency states, 2 capsules a day may be required or as directed by the physician.

Generally well tolerated. However, a few allergic reactions may be seen.

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Iron therapy is contraindicated in haemachromatosis and haemosiderosis, and in patients receiving repeated blood transfusion or with anaemia not due to by iron deficiency. It should be given cautiously to patients taking Levodopa as one of the ingredients (Pyridoxine) reduces the effect of Levodopa.

Care should be taken in patients who may develop iron overload, such as those with hemochromatosis, haemolytic anaemia or red cell aplasia. Iron chelates with tetracycline and absorption may be impaired.

Care should be taken when given to patients with Iron storage or Iron absorption disease. Iron form chelates with antacids and Tetracycline and absorption of all these may be impaired if taken concurrently

It is recommended during pregnancy and lactation.

Accidental overdose of iron containing products is a leading cause of fatal poisoning in children fewer than 6. Avoid higher doses if you have liver disease or hemochromatosis; excess can cause bloody diarrhea, vomiting, acidosis, darkened stools, abdominal pain. Symptoms may clear in a few hours. Riboflavin is reported to be completely safe and no toxic symptoms have been reported so far. Higher doses of Nicotinamide may cause vomiting, diarrhea. Sensory neuropathy was observed in individuals consuming more than 200 mg Pyridoxine for very long periods. No cases of Folic acid overdosages have been reported. Acute ingestion of Ascorbic acid, even of massive doses, is unlikely to cause significant effects.

Store in a dry place below 25° C. Protect from light.

Drugs for subcutaneous and mycoses, Drugs used in Vaginal and Vulval condition

Nystatin is an antifungal antibiotic. Which has fungistatic or fungicidal activity against variety of pathogenic and nonpathogenic yeast and fungi, including Candida albicans. Nystatin exerts its antifungal activity by binding to sterols in the fungal cell membrane. As a result of binding, the membrane is no longer able to function as a selective barrier, and potassium and other cellular constituents are lost. It is poorly absorbed from the gastrointestinal tract.

Children:

• In intestinal and oral candidiasis (thrush): 1,00,000 units (1 ml) should be dropped into the mouth four times daily.The longer the suspension is kept in contact with the affected area in the mouth, before swallowing, the greater will be its effect.
• For prophylaxis in the newborn: The suggested dose is 1,00,000 units (1 ml) once daily or as prescribed by the physician.

Adult:

• For the treatment of intestinal or esophageal candidiasis: 5,00,000 units (5 ml) by mouth 3 or 4 times daily. The dose may be doubled, if required.
• For prophylaxis of intestinal candidiasis in adults: 10,00,000 units (10 ml) daily.
• For prophylaxis to suppress the over growth of Candida albicans in patients receiving broad spectrum antibiotic therapy: 10,00,000 units (10 ml) daily.
• For the treatment of dental sores and oral infection: 1,00,000 units (1 ml) suspension should be dropped into the mouth four times daily.

Elderly: Older people with intestinal candidiasis who are unable to swallow tablets should be given 5,00,000 units (5 ml) suspension four times daily.

Nausea, vomiting and diarrhoea have occasionally been reported with high doses of Nystatin. No systemic effects or allergic reactions have been associated with its oral dose.

There is no known contraindication to the use of Nystatin.

Absorption from the gastrointestinal tract is negligible, therefore no special precaution is required to apply in pregnancy and lactation.

Absorption of Nystatin from the gastrointestinal tract is negligible, therefore no special precautions apply in pregnancy.

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

It is indicated on prophylaxis of iron deficiency especially when inadequate diet calls for supplementary zinc and iron during pregnancy and anemia.

Iron, Vitamin & Mineral Combined preparation

Ferrous Ascorbate, Folic Acid & Zinc is a combination of three nutritional supplements. Ferrous Ascorbate is a combination of iron and vitamin C. Iron replenishes the iron stores in your body and corrects iron deficiency anemia. Vitamin C (ascorbate) is added to enhance the absorption of iron in the body. Folic Acid is a form of vitamin B. It plays a vital role in the formation of red blood cells, which carry oxygen throughout the body. It is also essential in pregnancy due to its role in the development of the unborn baby's brain and spinal cord. Zinc is a micromineral that provides nutrition.

Adult & Elderly: One tablet a day before or after meal (food independent absorption) or as directed by the physician. In more severe cases, two tablets a day may be required as prescribed by the physician.

Pediatric patients: Safety and effectiveness in pediatric patients have not been established.

Side effects of iron, folic acid and zinc supplementation are mild and transient. These include epigastric pain, nausea, constipation, vomiting, diarrhoea, heart burn, etc. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

It is contraindicated in patients with haemolytic anaemia and in conditions with increased hypersensitivity to any of its components and increased body iron content.

Care should be taken in patients who may develop iron overload, such as those with haemochromatosis, haemolytic anemia or red cell aplasia. Failure to respond to treatment may indicate other causes of anemia and should be further investigated.

Iron chelates with tetracycline. Since oral iron products interfere with absorption of oral tetracycline antibiotics, this product should not be taken within two hours of each other. Occasional gastrointestinal discomfort may be minimized by taking with meals. Absorption of iron may be impaired by concurrent administrations of penicillamine and antacid. In patients with renal failure, a risk of zinc accumulation may exist.

If pregnant, or planning to become pregnant or are currently breast-feeding please contact your physician, before taking or continuing the drug. Administration in first trimester of pregnancy should be avoided unless definite evidence of iron deficiency is observed. Prophylaxis of iron deficiency is justified during the remainder of pregnancy specifically when zinc supplementation is required.

The clinical course of acute iron overdosage can be variable. Initial symptoms may include abdominal pain, nausea, vomiting, diarrhoea, tarry stools, melena, hematemesis, hypotension, tachycardia, metabolic acidosis, hyperglycemia, dehydration, drowsiness, pallor, cyanosis, lassitude, seizures, shock and coma.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Fexofenadine Hydrochloride is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children. It is also indicated for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria.

Non-sedating antihistamines

Fexofenadine Hydrochloride is an antihistamine with selective peripheral H1-receptor antagonist activity. It is rapidly absorbed after oral administration and peak plasma concentration is reached in 2-3 hours. It does not appear to cross the blood brain barrier.

Seasonal Allergic Rhinitis-

Adults and children 12 years and older:

• Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
• In case of impaired renal function: 60 mg once daily

Children from 6 to 11 years:

• Tablet: 30 mg twice daily or 60 mg once daily
• In case of impaired renal function: 30 mg once daily

Children from 2 to 11 years

• Suspension: 30 mg or 5 ml twice daily
• In case of impaired renal function: 30 mg or 5 ml once daily

Chronic Idiopathic Urticaria-

Adults and children 12 years and older:

• Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily 
• In case of impaired renal function: 60 mg once daily

Children from 6 to 11 years:

• Tablet: 30 mg twice daily or 60 mg once daily
• In case of impaired renal function: 30 mg once daily

Children from 6 months to less than 2 years:

• Suspension: 15 mg or 2.5 ml (1/2 tsp) twice daily
• In case of impaired renal function: 15 mg or 2.5 ml (1/2 tsp) once daily

Children from 2 to 11 years:

• Suspension: 30 mg or 5 ml (1 tsp) twice daily
• In case of impaired renal function: 30 mg or 5 ml (1 tsp) once daily

Common side effects are headache, fatigue, drowsiness, nausea, dry mouth and gastrointestinal disturbances.

Contraindicated in patients with known hypersensitivity to Fexofenadine Hydrochloride or any of its ingredients.

Caution should be exercised in elderly patient and patient with decreased renal function.

Plasma concentration of Fexofenadine Hydrochloride have been increased when given with erythromycin or ketoconazole. Aluminium and magnesium hydroxide containing antacid reduces the absorption of Fexofenadine Hydrochloride.

US FDA pregnancy category of Fexofenadine Hydrochloride is C. So, Fexofenadine Hydrochloride should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

In case of an overdose, standard measures to remove any unabsorbed drug should be employed. Symptomatic and supportive treatment is recommended. There has been no reported case of an acute overdose of Fexofenadine hydrochloride.

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

Baclofen is indicated in-

• spasticity resulting from multiple sclerosis
• flexor spasms and concomitant pain, clonus and muscular rigidity
• skeletal muscle spasm resulting from rheumatic disorders
• spinal cord injuries and other spinal cord diseases
• cerebrovascular accidents or neoplastic or degenerative brain disease

Centrally acting Skeletal Muscle Relaxants

Baclofen inhibits both monosynaptic and polysynaptic reflexes at the spinal level by stimulating the GABA_B receptors, which inhibits the release of glutamate and aspartate. It may also act at intraspinal sites producing CNS depression. Baclofen also exerts an antinociceptive effect.

Adult & children over 10 years: 5 mg 3 times daily, preferably with or after food, gradually increased; max. 100 mg daily.

Children <10 years: Treatment is usually started with 2.5 mg (2.5 ml) given 4 times daily then raised according to requirement. Daily maintenance dose-

• 12 month-2 years: 10-20 mg (10-20 ml)
• 2 years-6 years: 20-30 mg (20-30 ml)
• 6 years-10 years: 30-60 mg (30-60 ml)

The most common adverse reactions associated with Baclofen are transient drowsiness, daytime sedation, dizziness, weakness and fatigue.

• Central Nervous System: Headache (<10%), insomnia (<10%), and rarely, euphoria, excitement, depression, confusion, hallucinations, paraesthesia, nightmares, muscle pain, tinnitus, slurred speech, co-ordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizures, respiratory depression.
• Cardiovascular: Hypotension (<10%), rare instances of dyspnoea, palpitation, chest pain, syncope.
• Gastrointestinal: Nausea (approximately 10%), constipation (<10%) and rarely, dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhoea and positive test for occult blood in stool.
• Genitourinary: Urinary frequency (<10%) and rarely, enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, haematuria.
• Other: Instances of rash, pruritus, ankle oedema, excessive perspiration, weight gain, nasal congestion, visual disturbances, hepatic function disorders and paradoxical increase in spasticity. Muscular hypotonia of a degree sufficient to make walking or movement difficult may occur but is usually relieved by readjusting the dosage. For this purpose, the daytime dosage may be reduced and the evening dosage increased.

Baclofen is contraindicated in patients with hypersensitivity to any component of this product.

Pregnancy category B3. Safe use of Baclofen during pregnancy has not been established. Baclofen crosses the placental barrier. Baclofen should only be administered to pregnant women when in the judgement of the physician concludes that the potential benefits outweigh the possible hazards. Baclofen is excreted in breast milk however evidence to date suggests that the quantities are so small that no undesirable effects on the infant would be expected.

Gastric lavage is important in case of severe overdose.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Baclofen is indicated in-

• spasticity resulting from multiple sclerosis
• flexor spasms and concomitant pain, clonus and muscular rigidity
• skeletal muscle spasm resulting from rheumatic disorders
• spinal cord injuries and other spinal cord diseases
• cerebrovascular accidents or neoplastic or degenerative brain disease

Centrally acting Skeletal Muscle Relaxants

Baclofen inhibits both monosynaptic and polysynaptic reflexes at the spinal level by stimulating the GABA_B receptors, which inhibits the release of glutamate and aspartate. It may also act at intraspinal sites producing CNS depression. Baclofen also exerts an antinociceptive effect.

Adult & children over 10 years: 5 mg 3 times daily, preferably with or after food, gradually increased; max. 100 mg daily.

Children <10 years: Treatment is usually started with 2.5 mg (2.5 ml) given 4 times daily then raised according to requirement. Daily maintenance dose-

• 12 month-2 years: 10-20 mg (10-20 ml)
• 2 years-6 years: 20-30 mg (20-30 ml)
• 6 years-10 years: 30-60 mg (30-60 ml)

The most common adverse reactions associated with Baclofen are transient drowsiness, daytime sedation, dizziness, weakness and fatigue.

• Central Nervous System: Headache (<10%), insomnia (<10%), and rarely, euphoria, excitement, depression, confusion, hallucinations, paraesthesia, nightmares, muscle pain, tinnitus, slurred speech, co-ordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizures, respiratory depression.
• Cardiovascular: Hypotension (<10%), rare instances of dyspnoea, palpitation, chest pain, syncope.
• Gastrointestinal: Nausea (approximately 10%), constipation (<10%) and rarely, dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhoea and positive test for occult blood in stool.
• Genitourinary: Urinary frequency (<10%) and rarely, enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, haematuria.
• Other: Instances of rash, pruritus, ankle oedema, excessive perspiration, weight gain, nasal congestion, visual disturbances, hepatic function disorders and paradoxical increase in spasticity. Muscular hypotonia of a degree sufficient to make walking or movement difficult may occur but is usually relieved by readjusting the dosage. For this purpose, the daytime dosage may be reduced and the evening dosage increased.

Baclofen is contraindicated in patients with hypersensitivity to any component of this product.

Pregnancy category B3. Safe use of Baclofen during pregnancy has not been established. Baclofen crosses the placental barrier. Baclofen should only be administered to pregnant women when in the judgement of the physician concludes that the potential benefits outweigh the possible hazards. Baclofen is excreted in breast milk however evidence to date suggests that the quantities are so small that no undesirable effects on the infant would be expected.

Gastric lavage is important in case of severe overdose.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Febuxostat is indicated for the chronic management of hyperuricemia in patients with gout. Febuxostat is not recommended for the treatment of asymptomatic hyperuricemia.

Drugs used in Gout

Febuxostat is a non-purine, selective xanthine oxidase (XO) inhibitor. It decreases serum uric acid level by inhibiting xanthine oxidase, which is responsible for uric acid production. Xanthine oxidase breaks down hypoxanthine to xanthine and thus to uric acid. Febuxostat is not expected to inhibit other enzymes involved in purine and pyrimidine synthesis and metabolism at therapeutic concentrations.

Febuxostat is recommended at 40 mg or 80 mg once daily. The recommended starting dose of Febuxostat is 40 mg once daily. For patients who do not achieve a serum uric acid less than 6 mg /dL after 2 weeks with 40 mg, Febuxostat 80 mg is recommended. Febuxostat can be administered without regard to food or antacid use. No dose adjustment is necessary when administering Febuxostat to patients with mild to moderate renal or hepatic impairment.

The most common adverse events associated with the use of Febuxostat may include liver function abnormalities, nausea, arthralgia, and rash.

Febuxostat is contraindicated in patients being treated with azathioprine, mercaptopurine, or theophylline.

Gout Flare: An increase in gout flares is frequently observed during initiation of anti-hyperuricemic agents, including Febuxostat. If a gout flare occurs during treatment, Febuxostat need not be discontinued. Prophylactic therapy (i.e., non-steroidal anti-inflammatory drug (NSAID) or colchicine upon initiation of treatment) may be beneficial for up to six months.

Cardiovascular Events: A higher rate of cardiovascular thromboembolic events was observed in patients treated with febuxostat than allopurinol in clinical trials. Monitor for signs and symptoms of MI and stroke.

Liver Enzyme Elevation: Transaminase elevations have been observed in febuxostat -treated patients. Monitor liver function tests periodically.

Concomitant administration of Febuxostat with azathioprine, mercaptopurine or theophylline could increase plasma concentrations of these drugs resulting in severe toxicity.

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Febuxostat should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk. Caution should be exercised when Febuxostat is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in pediatric patients under 18 years of age have not been established

Febustat was studied in healthy subjects in doses up to 300 mg daily for seven days without evidence of dose-limiting toxicities.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Febuxostat is indicated for the chronic management of hyperuricemia in patients with gout. Febuxostat is not recommended for the treatment of asymptomatic hyperuricemia.

Drugs used in Gout

Febuxostat is a non-purine, selective xanthine oxidase (XO) inhibitor. It decreases serum uric acid level by inhibiting xanthine oxidase, which is responsible for uric acid production. Xanthine oxidase breaks down hypoxanthine to xanthine and thus to uric acid. Febuxostat is not expected to inhibit other enzymes involved in purine and pyrimidine synthesis and metabolism at therapeutic concentrations.

Febuxostat is recommended at 40 mg or 80 mg once daily. The recommended starting dose of Febuxostat is 40 mg once daily. For patients who do not achieve a serum uric acid less than 6 mg /dL after 2 weeks with 40 mg, Febuxostat 80 mg is recommended. Febuxostat can be administered without regard to food or antacid use. No dose adjustment is necessary when administering Febuxostat to patients with mild to moderate renal or hepatic impairment.

The most common adverse events associated with the use of Febuxostat may include liver function abnormalities, nausea, arthralgia, and rash.

Febuxostat is contraindicated in patients being treated with azathioprine, mercaptopurine, or theophylline.

Gout Flare: An increase in gout flares is frequently observed during initiation of anti-hyperuricemic agents, including Febuxostat. If a gout flare occurs during treatment, Febuxostat need not be discontinued. Prophylactic therapy (i.e., non-steroidal anti-inflammatory drug (NSAID) or colchicine upon initiation of treatment) may be beneficial for up to six months.

Cardiovascular Events: A higher rate of cardiovascular thromboembolic events was observed in patients treated with febuxostat than allopurinol in clinical trials. Monitor for signs and symptoms of MI and stroke.

Liver Enzyme Elevation: Transaminase elevations have been observed in febuxostat -treated patients. Monitor liver function tests periodically.

Concomitant administration of Febuxostat with azathioprine, mercaptopurine or theophylline could increase plasma concentrations of these drugs resulting in severe toxicity.

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Febuxostat should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk. Caution should be exercised when Febuxostat is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in pediatric patients under 18 years of age have not been established

Febustat was studied in healthy subjects in doses up to 300 mg daily for seven days without evidence of dose-limiting toxicities.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Flupentixol and Melitracen tablet is indicated in-

• Anxiety
• Depression
• Apathy
• Psychogenic depression.
• Depressive neurosses.
• Masked depression.
• Psychosomatic affections accompanied by anxiety and apathy.
• Menopausal depressions.
• Dysphoria and depression in alcoholics and drug addicts.

Combined anxiolytics & anti-depressant drugs

This consists of two well known and well proven compounds: flupentixol-a neuroleptic with anxiolytic and antidepressant properties of its own when given in small doses, and melitracen-a bipolar thymoleptic with activating properties in low doses. In combination the compounds render a preparation with antidepressant, anxiolytic and activating properties. Maximal serum concentration is reached in about 4 hours after oral administration of flupentixol and in about 4 hours after oral administration of melitracen. The biological half-life of flupentixol is about 35 hours and that of melitracen is about 19 hours. The combination of flupentixol and melitracen does not seem to influence the pharmacokinetic properties of the individual compounds.

Adults: Usually 2 tablets orally daily in the morning and noon. In severe cases, the morning dose may be increased to 2 tablets.

Elderly patients: 1 tablet in the morning.

Maintenance dose: Usually 1 tablet orally in the morning. In cases of insomnia or severe restlessness, additional treatment with a sedative in the acute phase is recommended.

In the recommended doses side effects are rare. These could be transient restlessness and insomnia.

If previously the patient has been treated with tranquillizers with sedative effect these should be withdrawn gradually.

This tablet may enhance the response to alcohol, barbiturates and other CNS depressants. Simultaneous administration of MAO-inhibitors may cause hypertensive crises. Neuroleptics and thymoleptics reduce the antihypertensive effect of guanethidine and similar acting compounds and thymoleptics enhance the effects of adrenaline and noradrenaline.

This tablet should preferably not be given during pregnancy and lactation.

In cases of overdosage the symptoms of intoxications by melitracen, especially of anticholinergic nature, dominate. More rarely extrapyramidal symptoms due to flupentixol occur. Symptomatic and Supportive. Gastric lavage should be carried out as soon as possible and activated charcoal may be administered. Measures aimed at supporting the respiratory and cardiovascular systems should be instituted. Epinephrine (adrenaline) must not be used for such patients. Convulsions may be treated with diazepam and extrapyramidal symptoms with biperiden.

Store at a temperature not exceeding 30°C in a dry place. Protect from light. Keep out of reach of children.

Letrozole is indicated for the first-line treatment of advanced/metastatic breast cancer (hormone receptor positive or receptor status unknown) in post-menopausal women.

Hormonal Chemotherapy

Mechanism of Action: Letrozole is a potent and highly specific nonsteroidal aromatase inhibitor. It inhibits the aromatase enzyme by competitively binding to the haem of the cytochrome P450 subunit of the enzyme, resulting in a reduction of estrogen biosynthesis in all tissues. Letrozole exerts its antitumor effect by depriving estrogen-dependent breast cancer cells of their growth stimulus. In postmenopausal women, estrogens are derived mainly from the action of the aromatase enzyme, which coverts adrenal androgens primarily androstenedione and testosterone-to oestrone (E1) and oestradiol (E2). The suppression of estrogen biosynthesis in the peripheral tissues and the malignant tissues can be achieved by specifically inhibiting the aromatase enzyme.

In healthy postmenopausal women, single doses of 0.1, 0.5 and 2.5mg letrozole suppress serum oestrone and oestradiol by 75-78% and 78% from baseline respectively. Maximum suppression is achieved in 48-78 hours. In post-menopausal patients, with advanced breast cancer, daily doses of 0.1 to 5mg suppress plasma concentration of oestradiol, oestrone, and oestrone sulphate by 78-95% from baseline in all patients treated. Letrozole had no effect on plasma androgen concentrations (androstenedione and testosterone) among healthy postmenopausal women after single doses of 0.1, 0.5 and 2.5mg indicating that the blockade of estrogen biosynthesis does not lead to accumulation of androgenic precursors. Impairment of adrenal steroidogenesis has not been observed.

Pharmacokinetics: Letrozole is rapidly and completely absorbed from the gastrointestinal tract (absolute bioavailability 99.9%). Food slightly decreases the rate of absorption, but the extent of absorption remains unchanged. The minor effect of the absorption rate is not considered to be of clinical relevance and therefore letrozole may be taken after, with or before food. Plasma protein binding of letrozole is approximately 60%, mainly to albumin (55%). The concentration of letrozole in erythrocytes is about 80% of that in plasma. Metabolic clearance to a pharmacologically inactive carbinol metabolite is the major elimination pathway of letrozole but is relatively slow when compared to hepatic blood flow. The cytochrome P450 isoenzymes 3A4 and 2A6 were found to be capable of converting letrozole to this metabolite in vitro but their individual contributions to letrozole metabolism in vivo have not been established. The apparent terminal elimination half-life in plasma is about 2 days. After daily administration of 2.5mg of letrozole, steady-state levels are reached within 2 to 6 weeks.

The recommended dose of Letrozole is 2.5 mg once daily. Treatment with Letrozole should continue as long as tumor response is seen. The drug should be discontinued if tumor stops responding as judged by tumor progression. For elderly patients, no modification of the normal adult dosage regimen is necessary. No dosage adjustment is required for patients with mild to moderate hepatic impairment or renal impairment.

Adverse events associated with letrozole are generally mild to moderate and rarely severe enough to require discontinuation. Many can be attributed to either the underlying disease or the normal pharmacological consequence of oestrogen deprivation (hot flushes, hair thinning). The most frequently reported adverse events are musculoskeletal pain, arthralgia, headache, fatigue, nausea, dyspnoea, peripheral oedema, coughing, constipation, vomiting, chest pain, viral infection, diarrhoea, rash, abdominal pain, dyspepsia and anorexia. Dizziness, weight increase and pruritus are less commonly seen.

Letrozole is contraindicated in known or suspected hypersensitivity to letrozole, other aromatase inhibitors, or to any of their ingredients. It is contraindicated during pregnancy, lactation and in pre-menopausal women. It is also contraindicated in severe hepatic dysfunction.

In breast cancer patients with moderate hepatic dysfunction, no dosage adjustment is necessary, but caution is recommended since letrozole elimination depends mainly on intrinsic metabolic clearance. Renal impairment (calculated creatinine clearance: 20 to 50 ml/min) did not affect steady-state plasma letrozole concentration at a dose of 2.5 mg or 5 mg. Hence, no dose adjustment is necessary for such renal function impairment. It is anticipated that letrozole could be removed from blood by dialysis since it is weakly bound to plasma proteins. The potential risks and benefits to such patients should be considered carefully before prescribing letrozole. In some cases, fatigue and dizziness have been observed with the use of letrozole. Patients should therefore, be advised that their physical and/or mental abilities required for operating machinery or driving a car may be impaired.

Clinical interaction studies with cimetidine and warfarin indicated that the co-administration of letrozole with these drugs does not result in clinically significant drug reactions, even through cimetidine is a known inhibitor of one of the cytochrome P450 isoenzymes capable of metabolising letrozole in vitro.

Oral administration of letrozole in pregnant rats resulted in teratogenicity and maternal toxicity at 0.03 mg/kg. Embryotoxicity and foetotoxicity were seen at doses >0.003 mg/kg and there was an increase in the incidence of foetal malformation among the animals treated. However, there are no adequate and well-controlled studies of letrozole in pregnant women and its use in these patients is not recommended. It is not known whether letrozole is excreted in human milk. Because many drugs are excreted in human milk, letrozole should not be administered to a nursing woman.

There is no clinical experience of overdosage. There is no specific antidote to letrozole. Since letrozole is not highly protein-bound, dialysis may be helpful. Emesis may be induced if the patient is alert. In general, supportive care and frequent monitoring of vital signs is appropriate.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Drugs for Infertility, Drugs for menopausal symptoms: Hormone replacement therapy, Female Sex hormones

Estriol induces the normalization of the vaginal epithelium and thus helps to restore the normal microflora and the physiological pH in the vagina. As a result, it increases the resistance of the vaginal epithelial cells to infection and inflammation. In comparison to other estrogens, estriol is short acting. In the years just before and after the menopause (which can be natural or surgically induced) estriol can be used in the treatment of symptoms and complaints related to estrogen deficiency. Estriol is particularly used in the treatment of urogenital symptoms.

After oral administration, estriol is rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma levels of unconjugated estriol are reached within 1 hr of administration. Nearly all (90%) estriol is bound to albumin in the plasma and unlike other estrogens; estriol is hardly bound to sex hormone-binding globulin. The metabolism of estriol consists mainly of conjugation and deconjugation during enterohepatic circulation. Estriol, a metabolic end product, is mainly excreted via the urine in the conjugated form. Only a small fraction is excreted via the feces, mainly as unconjugated estriol.

It is important that the total daily dose is taken at one time. It may be taken with or without food.

• Atropy of the lower urogenital tract: 4-8 mg/day for the first weeks, followed by a gradual reduction, based on relief of symptoms, until a maintenance dosage (e.g. 1-2 mg/day) is reached.
• Pre and postoperative therapy in postmenopausal women undergoing vaginal surgery: 4-8 mg/day in the 2 weeks before surgery; 1-2 mg/day in the 2 weeks after surgery.
• Climacteric complaints such as hot flushes and night sweating: 4-8 mg/day during the first weeks, followed by a gradual reduction. For maintenance therapy the lowest effective dosage should be used.
• A diagnostic aid in case of a doubtful atrophic cervical smear: 2-4 mg/day for 7 days before taking the next smear.
• Infertility due to cervical hostility: In general 1-2 mg/day on days 6-15 of the menstrual cycle. However, for some patients dosages as low as 1 mg/day are sufficient, whereas others may need up to 8 mg/day. Therefore, the dosage should be increased each month until an optimal effect on the cervical mucus is obtained.

Breast tension or pain, nausea, spotting, fluid retention and cervical hypersecretion may occasionally occur and be indicative of too high dosage. Headache, hypertension, leg cramps and vision disturbances are seldom observed. In general, most of these adverse reactions disappear after the 1 st week of treatment.

Breast enlargement, vaginal candidiasis, change in vaginal bleeding pattern, vomiting, stomach cramps, cholestatic jaundice, chloasma or melasma, erythema multiforme, erythema nodosum, hemorrhagic eruption, mental depression, chorea, increasing or decreasing body weight, edema, changes in libido.

Contraindicated in pregnancy, known or suspected estrogen-dependent tumours, undiagnosed vaginal bleeding, untreated endometrial hyperplasia, known or suspected breast cancer.

During prolonged treatment with estrogens, periodic medical examinations are advisable. With vaginal infections, a concomitant specific treatment is recommended. In order to prevent endometrial stimulation, the daily dose should not exceed 8 mg nor should this maximum dose be used for longer than several weeks. Patients with any of the following conditions should be monitored: A history of latent or overt cardiac failure, fluid retention due to renal dysfunction, hypertension, epilepsy or migraine (or a history of these conditions), severe liver disorders, endometriosis, fibrocystic mastopathy, porphyria, hyperlipoproteinaemia, a history during pregnancy or previous use of steroids of severe pruritus, cholestatic jaundice or herpes gestationis. Estrogen is reported to increase the risk of endometrial carcinoma in postmenopausal women. Use with precaution in gallbladder disorders, hypercalcemia, additional progestin, hypercoagulability, urethral bleeding and mastodynia.

There are strong indications that estrogens, estriol included, can increase the pharmacologic effects of certain corticosteroids. If necessary, the dosage of the corticosteroid should be reduced. There are also some indications, mainly obtained with other estrogens or oral contraceptives, that concurrent use of estriol with activated charcoal, barbiturates, hydantoins and rifampicin may possibly decrease the effectiveness of estriol.

Estriol is contraindicated during pregnancy. Use Estriol in breastfeeding women only if really needed, as estriol is excreted in the milk and it may decrease the quality and quantity of the milk production.

Symptoms that may occur in the case of an acute overdosage are nausea, vomiting and possibly withdrawal bleeding in females. No specific antidote is known. If necessary, a symptomatic treatment should be instituted.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Drugs for Infertility, Drugs for menopausal symptoms: Hormone replacement therapy, Female Sex hormones

Estriol Cream is a Hormone Replacement Therapy (HRT). It contains the female hormone estriol (an estrogen). During menopause Estriol is used in vagina which is slowly released and absorbed into the surrounding area and into the bloodstream.

Estriol induces the normalization of the vaginal epithelium and thus helps to restore the normal microflora and the physiological pH in the vagina. As a result, it increases the resistance of the vaginal epithelial cells to infection and inflammation. In comparison to other estrogens, estriol is short acting. In the years just before and after the menopause (which can be natural or surgically induced) estriol can be used in the treatment of symptoms and complaints related to estrogen deficiency. Estriol is particularly used in the treatment of urogenital symptoms.

Estriol cream should be used as per physician's advice. Each dose of cream contains 0.5 mg estriol.

• For vulvo-vaginal complaints associated with menopause: Initially one dose of cream per day for 3 weeks. Later you may only need one dose of cream twice a week.
• Before surgery: One dose of cream daily 2 weeks before the operation. When having a Pap smear your doctor may recommend a daily application of cream for 7 days.

How to apply the cream:

• Remove cap from the tube, invert it, and use the sharp point to open the tube.
• Pull the plunger up to the ring. Now attach it to the opening of the tube.
• Squeeze the tube slowly to fill the applicator to the ring-mark (where the plunger stops).
• Remove the tube.
• To apply the cream, lie down; insert the applicator deep into the vagina.
• Slowly push the plunger all the way in until the applicator is empty
• After use, pull the plunger out of the barrel beyond the point of resistance and wash both parts in warm, soapy water. Do not use detergents. Rinse well and dry afterwards. Do not put the applicator in hot or boiling water.
• The applicator can be re-assembled by fully inserting the plunger into the barrel beyond the point where resistance is felt.
• Discard the applicator once the tube is empty. Take Estriol cream before taking rest or going to sleep.If you forget a dose, use it as soon as you remember. But if you remember your missed dose at the time of your next dose, do not use an extra dose. Do not use a double dose to make up for the missed dose. This may increase the chance of you getting an unwanted side effect.

Do not use Estriol cream if:

• You have or have ever had breast cancer, or if you are suspected of having it, ovarian cancer, heart attack, stroke, angina, liver disease , thrombosis, pulmonary embolism, vaginal cancer.
• You are pregnant or think you may be pregnant
• You have any unexplained vaginal bleeding, blood clotting disorder, endometrial hyperplasia, porphyria, and various kind of allergic reaction.
• Jaundice, migraine pain, high blood pressure & breathing problem
• You have had an allergic reaction to estriol, or any of the other ingredients of estriol

Patients should keep under doctor’s observation for any Hormone Replacement Therapy (HRT). Same role is applicable for the application of Estriol cream. Doctor will give continuous advice regarding risks & benefts of the drug. But in case of jaundice, sudden high blood pressure, migraine, severe headache or pregnancy, the use of Estriol cream will be stopped immediately. Children’s are not allowed to use Estriol cream.

Interaction is found with Anticoagulants,corticosteroid hormones, succinylcholine, theophyllines, and medicines for epilepsy, medicines for fungal or bacterial infections, viral infections, and herbal preparations containing St John's Wort. As a result irregular bleeding may occur.

This medicine is contraindicated during pregnancy & lactation.

Store below 25°C. Protect from light and moisture. Keep out of reach of children.

Ferric Carboxymaltose is indicated for the treatment of iron deficiency anemia in adult patients-

• Who have intolerance to oral iron or have had unsatisfactory response to oral iron
• Who have non-dialysis dependent chronic kidney disease.

Parenteral Iron Preparations

Non-dextran, IV is a colloidal iron hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron; replaces iron stores found in hemoglobin, myoglobin, and enzymes; works to transport oxygen via hemoglobin Macrophage engulf FCM from blood and control iron release. Transferrin saturates and, Iron into the liver, spleen and Bone marrow.

For patients weighing 50 kg or more: Give Ferric Carboxymaltose in two doses separated by at least 7 days. Give each dose as 750 mg for a total cumulative dose not to exceed 1500 mg of iron per course.

For patients weighing less than 50 kg: Give Ferric Carboxymaltose in two doses separated by at least 7 days. Give each dose as 15 mg/kg body weight for a total cumulative dose not to exceed 1500 mg of iron per course.

The dosage of Ferric Carboxymaltose is expressed in mg of elemental iron. Each mL of Ferric Carboxymaltose contains 50 mg of elemental iron. Ferric Carboxymaltose treatment may be repeated if iron deficiency anemia reoccurs.

Administer Ferric Carboxymaltose intravenously, either as an undiluted slow intravenous push or by infusion. When administering as a slow intravenous push, give at the rate of approximately 100 mg (2 mL) per minute. When administered via infusion, dilute up to 750 mg of iron in no more than 250 mL of sterile 0.9% sodium chloride injection, USP, such that the concentration of the infusion is not less than 2 mg of iron per mL and administer over at least 15 minutes.

When added to an infusion bag containing 0.9% Sodium Chloride Injection, USP, at concentrations ranging from 2 mg to 4 mg of iron per mL, Ferric Carboxymaltose solution is physically and chemically stable for 72 hours when stored at room temperature. To maintain stability, do not dilute to concentrations less than 2 mg iron/mL.

Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of Ferric Carboxymaltose is intended for single use only. Any unused drug remaining after injection must be discarded.

Avoid extravasation of Ferric Carboxymaltose since brown discoloration of the extravasation site may be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the Ferric Carboxymaltose administration at that site.

Nausea, Hypertension, Flushing, Decreased blood phosphorus, Dizziness, Vomiting, Pruritus, Rash, Urticaria, Wheezing, Injection site discoloration, Headache, Increased alanine aminotransferase), Dysgeusia, Hypotension, Constipation, Serious anaphylactic/anaphylactoid reactions

Hypersensitivity to any of its components.

Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Ferric carboxymaltose. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Ferric carboxymaltose administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Ferric carboxymaltose when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Other serious or severe adverse reactions potentially associated with hypersensitivity which included, but not limited to, pruritus, rash, urticaria, wheezing, or hypotension may occur.

Hypertension: Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor patients for signs and symptoms of hypertension following each Ferric carboxymaltose administration.

There are no known drug interactions and none well documented.

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

Do not store above 30°C. Do not freeze.

Ferric Carboxymaltose is indicated for the treatment of iron deficiency anemia in adult patients-

• Who have intolerance to oral iron or have had unsatisfactory response to oral iron
• Who have non-dialysis dependent chronic kidney disease.

Parenteral Iron Preparations

Non-dextran, IV is a colloidal iron hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron; replaces iron stores found in hemoglobin, myoglobin, and enzymes; works to transport oxygen via hemoglobin Macrophage engulf FCM from blood and control iron release. Transferrin saturates and, Iron into the liver, spleen and Bone marrow.

For patients weighing 50 kg or more: Give Ferric Carboxymaltose in two doses separated by at least 7 days. Give each dose as 750 mg for a total cumulative dose not to exceed 1500 mg of iron per course.

For patients weighing less than 50 kg: Give Ferric Carboxymaltose in two doses separated by at least 7 days. Give each dose as 15 mg/kg body weight for a total cumulative dose not to exceed 1500 mg of iron per course.

The dosage of Ferric Carboxymaltose is expressed in mg of elemental iron. Each mL of Ferric Carboxymaltose contains 50 mg of elemental iron. Ferric Carboxymaltose treatment may be repeated if iron deficiency anemia reoccurs.

Administer Ferric Carboxymaltose intravenously, either as an undiluted slow intravenous push or by infusion. When administering as a slow intravenous push, give at the rate of approximately 100 mg (2 mL) per minute. When administered via infusion, dilute up to 750 mg of iron in no more than 250 mL of sterile 0.9% sodium chloride injection, USP, such that the concentration of the infusion is not less than 2 mg of iron per mL and administer over at least 15 minutes.

When added to an infusion bag containing 0.9% Sodium Chloride Injection, USP, at concentrations ranging from 2 mg to 4 mg of iron per mL, Ferric Carboxymaltose solution is physically and chemically stable for 72 hours when stored at room temperature. To maintain stability, do not dilute to concentrations less than 2 mg iron/mL.

Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of Ferric Carboxymaltose is intended for single use only. Any unused drug remaining after injection must be discarded.

Avoid extravasation of Ferric Carboxymaltose since brown discoloration of the extravasation site may be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the Ferric Carboxymaltose administration at that site.

Nausea, Hypertension, Flushing, Decreased blood phosphorus, Dizziness, Vomiting, Pruritus, Rash, Urticaria, Wheezing, Injection site discoloration, Headache, Increased alanine aminotransferase), Dysgeusia, Hypotension, Constipation, Serious anaphylactic/anaphylactoid reactions

Hypersensitivity to any of its components.

Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Ferric carboxymaltose. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Ferric carboxymaltose administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Ferric carboxymaltose when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Other serious or severe adverse reactions potentially associated with hypersensitivity which included, but not limited to, pruritus, rash, urticaria, wheezing, or hypotension may occur.

Hypertension: Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor patients for signs and symptoms of hypertension following each Ferric carboxymaltose administration.

There are no known drug interactions and none well documented.

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

Do not store above 30°C. Do not freeze.