Therapeutic Class: Herbal and Nutraceuticals

Indications
Yohimbine is indicated in erectile dysfunction, loss of libido & exhaustion.

Description
The medicinal part of yohimbe is the bark. This evergreen tree grows up to 30 m in height. The bark is gray-brown and the inner fracture is reddish brown and grooved. It tastes bitter and the plant is odorless. The tree grows in the jungles of West Africa, Cameroon, Congo and Gabon. The main alkaloid present in the bark is Yohimbine.

Pharmacology
Yohimbe is a potent alpha-2 adrenoceptor blocker and a weak alpha-1 adrenergic antagonist with some antidopaminergic properties. Yohimbe interacts with adrenoceptors that are selectively stimulated by clonidine, alpha-methylnorepinephrine, tramazoline, guanabenz & guanfacin. It also interacts with compounds that are nonselectively stimulated by norepinephrine and epinephrine. Yohimbe has a modest beneficial effect in the management of erectile dysfunction. Because of the alpha-2 adrenergic blockade, the drug is an effective treatment for sexual disorders such as decreased libido and decreased sexual response, caused by selective serotonin reuptake inhibitors.

Dosage & Administration
1 capsule 3 times daily or as advised by the physician

Interaction
Theoretically, Yohimbe may counteract the hypotensive effect of antihypertensive medications, resulting inadequate blood pressure control. It may potentiate pharmaceutical MAO-inhibitors

Contraindications
The drug should not be used by patients with liver and kidney diseases, chronic inflammation of the sexual organs or prostate gland or with a history of gastric or duodenal ulcers

Side Effects
Anxiety states, elevated blood pressure, exanthema, nausea, insomnia, tachycardia, tremor, mania and vomiting.

Precautions & Warnings
Patients taking Yohimbe should avoid alcohol ingestion

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

Indications

• This combination mouthwash is indicated in-
• Gingivitis
• Oral hygiene
• Cavities
• Bad breath
• Plaque
• Gum disease
• Teeth cleaner &
• Brighter.

Composition
Each 100 ml mouthwash contains-

• Eucalyptol USP 92 mg
• Menthol USP 42 mg
• Methyl Salicylate BP 60 mg
• Thymol BP 64 mg
• Sodium Fluoride BP 20 mg

Pharmacology
Eucalyptol- is a natural organic compound which is a colorless liquid. It is a cyclic ether and a monoterpenoid. Eucalyptol is an ingredient in many brands of mouthwash and cough suppressant. It controls airway mucus hypersecretion and asthma via anti-inflammatory cytokine inhibition.

Menthol: It provides cooling sensation by stimulation of cooling receptor and gives local anesthetic action

Methyl Salicylate: It penetrates and reaches at high concentration in pain regions and inhibit the prostaglandin synthesis and relieves pain effectively

Thymol- one of the chemicals in thyme, is used with another chemical, chlorhexidine, as a dental varnish to prevent tooth decay. In foods, thyme is used as a flavoring agent. In manufacturing, red thyme oil is used in perfumes. It is also used in soaps, cosmetics, and toothpastes.

Fluoride salts- are often added to municipal drinking water (as well as certain food products in some countries) for the purposes of maintaining dental health. The fluoride enhances the strength of teeth by the formation of fluorapatite, a naturally occurring component of tooth enamel. Toothpaste often contains sodium fluoride to prevent cavities, although tin (II) fluoride is generally considered superior for this application.

Dosage & Administration
Use twice daily after brushing your teeth with toothpaste.Vigorously swish 10 ml of rinse between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing. Supervise children as necessary until capable of using without supervision.

Use in Children: According to the consultancy of dentist or physician.

Interaction
There are no known drug interactions and none well documented.

Side Effects
Do not eat or drink for 30 minutes after rinsing. Doing so will diminish the effects of the mouthwash.

Pregnancy & Lactation
Pregnancy Category: Not Classified. FDA has not yet classified the drug into a specified pregnancy category.

Precautions & Warnings
Should not eat or drink for 30 minutes after rinsing. Children under 12 years of age should be instructed in good rinsing habits to minimize swallowing. Children have to be supervised in rinsing as necessary until they are capable of using without supervision. If more than amount used for rinsing is accidentally swallowed, physicians help should be taken immediately.

Storage
Store in a cool & dry place. Keep out of reach of children. Cold weather may cloud this product but its antiseptic & anticavity properties are not affected.

Pharmacology
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.

Dosage
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.

Administration
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.

Interaction
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.

Contraindications
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

Side Effects
Local irritation or itching of vagina, Swelling and increased tenderness of the breasts, Increased vaginal discharge, Nausea, Fluid retention in the tissues, usually marked by swollen ankles or feet.
In most patients these side effects will disappear after the first weeks of treatment. Tell your doctor if vaginal bleeding occurs or if any side effect becomes troublesome or persists.
Other side effects which may occur with HRT are benign and malignant hormone-dependent tumors such as endometrial cancer, heart attack and stroke, gall bladder disease, skin problems such as rashes, discoloration or red patches on the skin, various skin diseases with blisters and nodules or bleeding into the skin, venous thromboembolism or deep leg or pelvic venous thrombosis and pulmonary embolism (see Before you use Estriol Cream). Using HRT for several years slightly increases the risk of breast cancer.

Pregnancy & Lactation
This medicine is contraindicated during pregnancy & lactation.

Precautions & Warnings
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 are not allowed to use Estriol cream.

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

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

Indications
Estriol tablet is indicatd in-

• Atrophy of the lower urogenital tract related to oestrogen deficiency, notably for the treatment of vaginal complaints such as dyspareunia, dryness and itching, for the prevention of recurrent infections of the vagina and lower urinary tract, in the management of micturition complaints (such as frequency and dysuria) and mild urinary incontinence.
• Pre and postoperative therapy in postmenopausal women undergoing vaginal surgery
• Climacteric complaints such as hot flushes and night sweating
• A diagnostic aid in case of a doubtful atrophic cervical smear
• Infertility due to cervical hostility.

Pharmacology
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.

Dosage & Administration
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.

Interaction
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.

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

Side Effects
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.

Pregnancy & Lactation
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.

Precautions & Warnings
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.

Overdose Effects
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.

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

Dosage
Safety of daily doses above 20 mg has not been demonstrated. Escitalopram Oxalate is administered as a single daily dose and may be taken with or without food.

Major depressive episodes: Usual dosage is 10 mg once daily. Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily. Usually, 2-4 weeks are necessary to obtain an antidepressant response. After the symptoms resolve, treatment for at least 6 months is required for consolidation of the response.

Panic disorder with or without agoraphobia: An initial dose of 5 mg is recommended for the first week before increasing the dose to 10 mg daily. The dose may be further increased, up to a maximum of 20 mg daily, dependent on individual patient response. Maximum effectiveness is reached after about 3 months. The treatment lasts several months.

Social anxiety disorder: Usual dosage is 10 mg once daily. Usually, 2-4 weeks are necessary to obtain symptom relief. The dose may subsequently, depending on individual patient response, be decreased to 5 mg or increased to a maximum of 20 mg daily. Social anxiety disorder is a disease with a chronic course, and treatment for 12 weeks is recommended to consolidate response. Long-term treatment of responders has been studied for 6 months and can be considered on an individual basis to prevent relapse; treatment benefits should be re-evaluated at regular intervals. Social anxiety disorder is a well-defined diagnostic terminology of a specific disorder, which should not be confounded with excessive shyness. Pharmacotherapy is only indicated if the disorder interferes significantly with professional and social activities. The place of this treatment compared to cognitive behavioural therapy has not been assessed. Pharmacotherapy is part of an overall therapeutic strategy.

Generalised anxiety disorder: Initial dosage is 10 mg once daily. Depending on the individual patient response, the dose may be increased to a maximum of 20 mg daily. Long term treatment of responders has been studied for at least 6 months in patients receiving 20 mg/day. Treatment benefits and dose should be re-evaluated at regular intervals.

Obsessive-Compulsive Disorder: Initial dosage is 10 mg once daily. Depending on the individual patient response, the dose may be increased to a maximum of 20 mg daily. As OCD is a chronic disease, patients should be treated for a sufficient period to ensure that they are symptom-free. Treatment benefits and dose should be re-evaluated at regular intervals.

Administration
Escitalopram should generally be administered once daily, morning or evening with or without food.

Interaction
As SSRI or related antidepressants should not be started until 2 weeks after stopping an MAOI. Conversely, an MAOI should not. be started until at least a week after an SSRI or related antidepressant has been stopped (2 weeks in the case of paroxetine and sertraline, at least 5 weeks in the case of fluoxetine).

Contraindications
Escitalopram is contraindicated in patients with known hypersensitivity to Escitalopram or Citalopram or any of the inactive ingredients of the drug product. Concomitant use of escitalopram in patients taking monoamine oxidase/pimozide is contraindicated.

Side Effects
SSRIs are less sedating and have fewer antimuscarinic and cardiotoxic effects than tricyclic antidepressants. Side-effects of the SSRIs include gastrointestinal effects (dose-related and fairly common include nausea, vomiting, dyspepsia, abdominal pain, diarrhoea, constipation), anorexia with weight loss (increased appetite and weight gain also reported) and hypersensitivity reactions including rash, urticaria, angioedema, anaphylaxis, arthralgia, myalgia, and photosensitivity; other side-effects include dry mouth, nervousness, anxiety, headache, insomnia, tremor, dizziness, asthenia, hallucinations, drowsiness, convulsions, galactorrhoea, sexual dysfunction, urinary retention, sweating, hypomania or mania, movement disorders and dyskinesias, visual disturbances.

Pregnancy & Lactation
When treating a pregnant woman with Escitalopram during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. It is excreted in human breast milk. The decision whether to continue or discontinue either nursing or Escitalopram therapy should take into account the risk of citalopram exposure for the infant and the benefits Escitalopram treatment for the mother.

Precautions & Warnings
SSRIs should be used with caution in patients with epilepsy (avoid if poorly controlled, discontinue if convulsions develop), concurrent electroconvulsive therapy (prolonged seizures reported with fluoxetine), history of mania, cardiac disease, diabetes mellitus, angle-closure glaucoma, concomitant use of drugs that increase risk of bleeding, history of bleeding disorders (especially gastro-lntestinal bleeding), hepatic and renal impairment.

Use in Special Populations
Elderly patients (>65 years of age): Initial dosage is 5 mg once daily. Depending on the individual patient response the dose may be increased to 10 mg daily. The efficacy of escitalopram in social anxiety disorder has not been studied in elderly patients.

Children and adolescents (<18 years): Escitalopram Oxalate should not be used in the treatment of children and adolescents under the age of 18 years.

Reduced renal function: Dosage adjustment is not necessary in patients with mild or moderate renal impairment. Caution is advised in patients with severely reduced renal function (CLCR less than 30 ml/min).

Reduced hepatic function: An initial dose of 5 mg daily for the first two weeks of treatment is recommended in patients with mild or moderate hepatic impairment. Depending on individual patient response, the dose may be increased to 10 mg daily. Caution and extra careful dose titration is advised in patients with severely reduced hepatic function.

Poor metabolizers of CYP2C19: For patients who are known to be poor metabolisers with respect to CYP2C19, an initial dose of 5 mg daily during the first two weeks of treatment is recommended. Depending on individual patient response, the dose may be increased to 10 mg daily. Discontinuation symptoms seen when stopping treatment. Abrupt discontinuation should be avoided.

When stopping treatment with escitalopram the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of discontinuation symptoms. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.

Overdose Effects
Symptoms: Symptoms seen in a reported overdose of escitalopram include symptoms mainly related to the central nervous system (ranging from dizziness, tremor, and agitation to rare cases of serotonin syndrome, convulsion, and coma), the gastrointestinal system (nausea/vomiting), and the cardiovascular system (hypotension, tachycardia, QT interval, prolongation, and arrhythmia) and electrolyte/fluid balance conditions (hypokalaemia, hyponatremia).

Management: There is no specific antidote. Establish and maintain an airway, ensure adequate oxygenation and respiratory function. Gastric lavage and the use of activated charcoal should be considered. Gastric lavage should be carried out as soon as possible after oral ingestion. Cardiac and vital signs monitoring are recommended along with general symptomatic supportive measures. ECG monitoring is advised in case of overdose, in patients with congestive heart failure/bradyarrhythmias, in patients using concomitant medications that prolong the QT-interval, or in patients with altered metabolism, e.g. liver impairment.

Storage
Store below 30°C temperature and protect from light & moisture. Keep the medicine out of the reach of children.

Therapeutic Class: Drugs for Haemolytic Hypoplastic & Renal Anemia

Indications
Erythropoietin Beta is indicated for:

• Treatment of symptomatic anemia associated with chronic kidney disease (CKD) in patients on dialysis.
• Treatment of symptomatic renal anemia in patients not yet undergoing dialysis.
• Prevention of anemia of prematurity in infants with a birth weight of 750 to 1500 g and a gestational age of less than 34 weeks.
• Treatment of symptomatic anemia in adult patients with non-myeloid malignancies receiving chemotherapy.
• Increasing the yield of autologous blood from patients in a pre-donation programme.

Its use in this indication must be balanced against the reported increased risk of thromboembolic events. Treatment should only be given to patients with moderate anemia (Hb 10–13 g/dl [6.21–8.07 mmol/l], no iron deficiency) if blood conserving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).

Pharmacology
Erythropoietin beta is identical in its amino acid and carbohydrate composition to erythropoietin that has been isolated from the urine of anemic patients. Erythropoietin is a glycoprotein that stimulates the formation of erythrocytes from its committed progenitors. It acts as a mitosis-stimulating factor and differentiation hormone. Erythropoietin is a glycoprotein that, as a growth factor, primarily stimulates the formation of erythrocytes from its committed progenitors. It acts as a mitosis-stimulating factor and differentiation hormone.

Dosage & Administration
Therapy with Recormon should be initiated by physicians experienced in the above mentioned indications. As anaphylactoid reactions were observed in isolated cases, it is recommended that the first dose be administered under medical supervision.

Substitution by any other biological medicinal product requires the consent of the prescribing physician.

The Recormon pre-filled syringe is ready for use. Only solutions which are clear or slightly opalescent, colourless and practically free of visible particles may be injected.

Recormon in pre-filled syringe is a sterile but unpreserved product. Under no circumstances should more than one dose be administered per syringe.

Treatment of anemic patients with chronic renal failure: The solution can be administered subcutaneously or intravenously. In case of intravenous administration, the solution should be injected over approximately 2 minutes, e.g. in hemodialysis patients via the arteriovenous fistula at the end of dialysis.

For non-hemodialysed patients, subcutaneous administration should always be preferred in order to avoid puncture of peripheral veins.

The recommended hemoglobin target is 10 -12 g/dl. The target hemoglobin should be determined individually in the presence of hypertension or existing cardiovascular, cerebrovascular or peripheral vascular diseases. It is recommended that hemoglobin is monitored at regular intervals (e.g. every two to four weeks) until stabilised and periodically thereafter.

Treatment with Recormon is divided into two stages: Correction phase-

Subcutaneous administration: The initial dosage is 3 x 20 IU/kg body weight per week. The dosage may be increased every 4 weeks by 3 X 20 IU/kg body weight/week if the Hb increase is not adequate (Hb <1.5 g/L per week). The weekly dose can also be divided into daily doses.

Intravenous administration: The initial dosage is 3 x 40 IU/kg per week. The dosage may be raised after 4 weeks to 80 IU/kg - three times per week- and by further increments of 20 IU/kg if needed, three times per week, at monthly intervals.

For both routes of administration, the maximum dose should not exceed 720 IU/kg per week.

Interaction
No dedicated clinical interaction studies have been performed. Clinical experience has not given evidence for potential interaction of Recormon with other medicinal products. In animal experiments epoetin did not increase the myelotoxicity of cytostatic medicinal products like etoposide, cisplatin, cyclophosphamide, and fluorouracil.

Contraindications
Erythropoietin Beta is contraindicated in patients with:

• Known hypersensitivity to the active substance or any of the excipients.
• Poorly controlled hypertension.

In the indication "increasing the yield of autologous blood", Recormon must not be used in patients who, in the month preceding treatment, have suffered a myocardial infarction or stroke, patients with unstable angina pectoris, or patients who are at increased risk of deep venous thrombosis such as those with a history of venous thromboembolic disease.

Side Effects
Rarely (≥1/10,000 to ≤1/1,000), skin reactions such as rash, pruritus, urticaria or injection site reactions may occur. In very rare cases (≤1/10,000) anaphylactoid reactions have been reported. However, in controlled clinical studies no increased incidence of hypersensitivity reactions was found. In very rare cases (≤1/10,000), particularly when starting treatment, flu-like symptoms such as fever, chills, headaches, pain in the limbs, malaise and/or bone pain have been reported. These reactions were mild or moderate in nature and subsided after a couple of hours or days.

Pregnancy & Lactation
Pregnancy: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. For epoetin beta, all safety information with regard to exposure to Recormon during pregnancies has been gained from post-marketing experience. A review of the available post-marketing data does not show evidence of a causal association between harmful effects with respect to pregnancy, embryonal/fetal development or postnatal development and treatment with Recormon. However in the absence of clinical study data, caution should be exercised when prescribing to pregnant women.

Lactation: Only limited experience in human lactation has been gained. Endogeneous erythropoietin is excreted in breast milk and readily absorbed by the neonatal gastrointestinal tract. A decision on whether to continue or discontinue breastfeeding or to continue or discontinue therapy with epoetin beta should be made taking into account the benefit of breastfeeding to the child and the benefit of epoetin beta therapy to the woman.

Use in Special Populations
Pediatric use: Results of pediatric clinical studies have shown that, on average, the younger the patients, the higher the Recormon doses required. Nevertheless, the recommended dosing schedule should be followed as the individual response cannot be predicted.

Geriatric use: No dedicated studies in geriatric patients were performed. A large proportion of geriatric patients were included in clinical trials with Recormon. A need for special dose adjustments in the geriatric population was not identified.

Hepatic Impairment: No dedicated clinical trials were conducted in patients with hepatic impairment. No special dosage Instructions are available.

Overdose Effects
The therapeutic range of Recormon is wide and individual response to therapy must be considered when Recormon treatment is initiated. Overdose can result in manifestations of an exaggerated pharmacodynamic effect, e.g. excessive erythropoiesis which may be associated with life-threatening complications of the cardiovascular system. In case of excessive hemoglobin levels, Recormon should be temporarily withheld. If clinically indicated, phlebotomy may be performed.

Storage
Store in a refrigerator 2°C–8°C. Keep the vial/cartridge/pre-filled syringe in the outer carton, in order to protect from light

Therapeutic Class: Drugs for Haemolytic Hypoplastic & Renal Anemia

Indications
Erythropoietin alfa is an erythropoiesis-stimulating agent (ESA) indicated for:
Treatment of anemia due to:

• Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis.
• Zidovudine in HIV-infected patients.
• The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.

Reduction of allogeneic RBC transfusions in patients undergoing elective, noncardiac, nonvascular surgery.

Prevention of anemia of prematurity in infants with a birth weight of 750 to 1500 gm and gestational age of less than 34 weeks.

Description
Erythropoietin alfa is recombinant human erythropoietin (EPO). It is expressed in Chinese hamster ovary cells and has a 165 amino acid sequence identical to that of human urinary EPO; the two are indistinguishable on the basis of functional assays. The apparent molecular weight of erythropoietin is about 30,400 daltons.

Therapeutic Class: Loop diuretics

Indications
Furosemide is indicated in-
Fluid retention associated with chronic congestive cardiac failure (if diuretic treatment is required).
Fluid retention associated with acute congestive cardiac failure.
Fluid retention associated with chronic renal failure.
Maintenance of fluid excretion in acute renal failure, including that due to pregnancy or burns.
Fluid retention associated with nephrotic syndrome (if diuretic treatment is required).
Fluid retention associated with liver disease (if necessary to supplement treatment with aldosterone antagonists).
Hypertension.
Hypertensive crisis (as a supportive measure).
Support of forced diuresis.

Pharmacology
Furosemide is a monosulphonyl diuretic. It is an effective diuretic that retains its activity even in low glomerular filtration rate (GFR). Furosemide has a distinctive action on renal tubular function. It affects a peak diuresis far greater than that observed with other agents. Other features are (I) prompt onset of action (II) inhibition of sodium and chloride transport in the ascending limb of the loop of Henle and (III) independence of their action from acid-base balance changes. Furosemide acts primarily to inhibit electrolyte reabsorption in the thick ascending limb of the loop of Henle. Furosemide is readily absorbed from the gastrointestinal tract and considerable proportions are bound to plasma proteins. It is rapidly excreted in the urine. With an hour after intravenous injection, its effect is evident in about 5 minutes and last for about 2 hours.

Dosage & Administration
Furosemide 40 mg Tablet-
Edema:

• Adults: The initial adult dose is 40 mg daily, reduced to 20 mg daily or 40mg on alternate days. In some patients daily doses of 80mg or higher (given in divided doses) may be required. The individually determined single dose should then be given once or twice daily (eg, at 8 am and 2 pm). For resistant edema, 80-120 mg daily. In patients with clinically severe edematous states the dose of furosemide may be carefully titrated up to 600 mg/day. When doses exceeding 80 mg/day are given for prolonged periods, careful clinical observation and laboratory monitoring are particularly advisable.
• Children: Neonate: 0.5-2 mg/kg every 12-24 hours (every 24 hours if postmenstrual age under 31 weeks).
• Child 1 month-12 years: 0.5-2 mg/kg 2-3 times daily (every 24 hours if postmenstrual age less than 31 weeks); higher doses may be required in resistant edema; max. 12 mg/kg daily, not to exceed 80 mg daily.
• Child 12-18 years:20-40 mg daily, increased in resistant edema to 80-120 mg daily.
• Elderly: In the elderly furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.

Furosemide 250 mg Tablet: For selected patients with advanced chronic renal failure, diuretic therapy may be started with Furosemide orally. If conventional doses (80 to 160 mg orally) fail to produce an adequate diuresis, a single dose of 250 mg is given as a starting dose. If a satisfactory diuresis does not ensue within 4-6 hours, the initial dose may be doubled to 500 mg. The criterion of optimal dosage is a urinary output of at least 2.5 liters per day. A maximum daily dose of 1000 mg should not be exceeded.

Furosemide Syrup: Furosemide Liquid has an exceptionally wide therapeutic range, the effect being proportional to the dosage. Furosemide Liquid is best given as a single dose either daily or on alternate days. The usual initial daily dose is 40 mg. This may require adjustment until the effective dose is achieved as a maintenance dose. In mild cases, 20 mg daily or 40 mg on alternate days may be sufficient, whereas in cases of resistant edema, daily doses of 80 mg and above may be used as one or two daily, or intermittently. Severe cases may require gradual titration of the furosemide dosage up to 600 mg daily. The recommended maximum daily dose of furosemide administration is 1,500 mg.

Furosemide Injection-
Edema:

Adults: Doses of 20-50 mg intramuscularly or intravenously may be given initially. If larger doses are required, they should be given increasing by 20 mg increments and not given more often than every two hours. If doses greater than 50 mg are required it is recommended that they should be given by slow intravenous infusion. The recommended maximum daily dose of furosemide administration is 1,500 mg.

By slow intravenous injection:

• Neonate: 0.5-1 mg/kg every 12-24 hours (every 24 hours if postmenstrual age under 31 weeks).
• Child 1 month-12 years: 0.5-1 mg/kg repeated every 8 hours as necessary;maximum 2 mg/kg (max. 40 mg) every 8 hours.
• Child 12-18 years: 20-40 mg repeated every 8 hours as necessary; higher doses may be required in resistant cases.

By continuous intravenous infusion:

• Child 1 month-18 years: 0.1-2 mg/kg/hour (following cardiac surgery, initially 100 micrograms/kg/hour, doubled every 2 hours until urine output exceeds 1 mL/kg/hour).
• Elderly: In the elderly furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.

Hypertension:

• Adults: Doses of 20 to 50 mg intramuscularly or intravenously may be given initially. If larger doses are required, they should be given increasing by 20 mg increments and not given more often than every two hours. If doses greater than 50 mg are required it is recommended that they should be given by slow intravenous infusion. The recommended maximum daily dose of furosemide administration is 1,500 mg. Children: Parenteral doses for children range from 0.5-1.5 mg/kg body weight daily up to a maximum total daily dose of 20 mg.
• Elderly: In the elderly furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.

Interaction

Therapeutic Class: Intracellular antibiotic

Indications
Fosfomycin Sodium IV Infusion is indicated for the treatment of the following infections in adults and children including neonates:

• Osteomyelitis
• Complicated urinary tract infections
• Nosocomial lower respiratory tract infections
• Bacterial meningitis
• Bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above

Fosfomycin should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of the infections listed above, or when these alternative antibacterial agents have failed to demonstrate efficacy.

Pharmacology
Fosfomycin exerts a bactericidal effect on proliferating pathogens by preventing the enzymatic synthesis of the bacterial cell wall. Fosfomycin inhibits the first stage of intracellular bacterial cell wall synthesis by blocking peptidoglycan synthesis.

Dosage
The daily dose of Fosfomycin is determined based on the indication, severity and site of the infection, susceptibility of the pathogen(s) to fosfomycin and the renal function.In children,it is also determined by age and body weight.

Adults and adolescents >12 years of age (>40 kg): Fosfomycin is primarily excreted renally unchanged. The general dosage guidelines for adults with estimated creatinine clearance >80 ml/min are as follows:

• Osteomyelitis: 12-24 gm in 2-3 divided doses
• Complicated urinary tract infection: 12-16 gm in 3 divided dose
• Nosocomial lower respiratory tract infection: 12-24 gm in 2-3 divided dose
• Bacterial meningitis: 16-24 gm in 3-4 divided doses

Individual doses must not exceed 8 gm. The high-dose regimen in 3 divided doses should be used in severe infections expected or known to be caused by less susceptible bacteria. There are limited safety data in particular for doses in excess of 16 g/day. Special caution is advised when such doses are prescribed.