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Multi-vitamin & Multi-mineral combined preparations, Specific mineral & vitamin combined preparations

Vitamins and minerals are essential for normal metabolic functions including hematopoiesis. The members of vitamin B-group are components of enzyme system that regulate various stages of carbohydrate, fat and protein metabolism, each of the components playing a specific biological role. Vitamin C is involved in tissue repair and collagen formation. Vitamin A plays an essential role in the function of retina and is essential for growth and differentiation of epithelial tissue. Vitamin E is an antioxidant which preserves essential cellular constituents. Vitamin D is supplemented for prevention and cure of nutritional and metabolic rickets and for treatment of hypoparathyroidism. Iron, Copper, Manganese, Zinc serve as catalysts in enzyme systems which perform vital cellular functions.

Orally one tablet daily for adult and children over 5 years of age or as directed by the physicians.

Side effects have been reported with specific vitamins & minerals, but at level substantially higher than those in this tablet. Iron has been associated with gastrointestinal intolerance in some patients.

This is contraindicated in patients hypersensitive to any of its components. This is not intended for treatment of severe specific deficiencies of vitamins or minerals. It is not recommended for patients undergoing treatment with levodopa as pyridoxine decreases the efficacy of levodopa. During the first trimester of pregnancy, larger doses of vitamin A (more than 10 tablets per day) may be teratogenic.

Not intended for treatment of pernicious anemia or other megaloblastic anemia where vitamin B12 is deficient.

During the first trimester of pregnancy, recommended daily dose should not be exceeded. Because larger doses of Vitamin-A (multiple tablets per day) may be teratogenic.

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

Permethrin cream is indicated for the treatment of scabies and crab lice infestations (Pediculosis). Scabies can affect everyone in the family. If one is infected, all family members must be treated together.

Parasiticidal preparations

Permethrin cream contains Permethrin, a pyrethroid, which is a topical scabicidal agent for the treatment of infestation with Sarcoptes Scabiei (scabies). It acts on the nerve cell membrane to disrupt the sodium channel current by which the polarization of the membrane is regulated. Delayed repolarization & paralysis of the pests are the consequences of this disturbance.

Pharmacokinetics: The only approved route of administration is the topical route and there are few human data available on systemic exposure or kinetics following permethrin application to the skin. Some presystemic metabolism occurs in skin. Less than 0.5% of applied permethrin is absorbed during the first 48 hours. Absorbed permethrin is rapidly metabolized by ester hydrolysis, most likely in the liver and the products are excreted primarily in the urine.

Recommended duration of Treatment:

• Adults and children over 12 years: a full tube
• Children aged 6-12 years: up to 1⁄2 of a tube
• Children aged 1-5 years: up to  ¼ of a tube
• Children aged 2 months to 1 year: up to ⅛ of a tube
• Children Less then 2 month: dose is not established

Before application of Permethrin cream the skin should be clean, cool and dry. Do not have a hot shower or bath before applying.

For adults and children over 2 years: Apply the cream to the whole body from the neck down, rubbing lightly into the skin until the cream disappears. It is important to include all skin surfaces, such as between the fingers and toes, under the nails and on the soles of the feet.

For babies under 2 years: Apply to the face, neck, ears and scalp as well, only avoiding the area immediately around the eyes and mouth.

Leave cream on for at least 8 hours, before washing off. Reapply to any area that may be washed during the 8h treatment time (such as after washing the hands). If necessary, permethrin cream should be used again after 7 days as per the advice of the doctor.

In Scabies patients, skin discomfort, usually described as burning, stinging or tingling occurs in a few individuals soon after the cream is applied. Others transient signs and symptoms of irritation including enythema, edema, eczema, rash and puritis.

Permethrin is contraindicated in patients with known hypersensitivity to any component of pyrethroids or permethrin. Nursing staff who routinely apply permethrin may wear globes to avoid any possible irritation to the hands.

Scabies infestation is often accompanied by pruritus, edema & erythema. Treatment with permethrin may temporarily exacerbate these conditions. Patients should be advised to avoid contact with eyes during application & to flash with water immediately if the cream gets in the eyes.

The treatment of eczemodous like reactions with corticosteroids should be withheld prior to treatment with permethrin, as there is a risk of exacerbating the scabies infestation by reducing the immune response to the mite.

In the absence of specific studies in pregnant women, its use in pregnancy should only follow medical advice. It is not known whether permethrin is excreted in human milk so it should not be used in nursing mothers.

Store in a cool, dry place, away from light & keep out of the reach of children...

This lotion is indicated for the treatment of scabies and pruritus.

Local Antipruritic, Parasiticidal preparations

Permethrin is a pyrethroid pediculocide and scabicide. It causes paralysis and death of the pest by inhibiting sodium ion influx through nerve cell membrane channels delaying repolarisation.

Crotamiton has scabicidal and antipruritic action against Sarcoptes scabei. It is an effective pediculocide as well.

Adult: Permethrin & Crotamiton lotion is suitable for adults, children of 2 months of age and above, and the elderly. It is for external use only and should not be applied to broken skin, mucous membranes or near the eyes. Permethrin & Crotamiton lotion should be applied to skin which is clean, dry and cool. It should not be used immediately after a hot bath. Permethrin & Crotamiton lotion is intended for a single application over the whole body. Permethrin & Crotamiton lotion should be left on for at least 8 hours. Reapply the lotion to the hands if they are washed within 8 hours of treatment. The whole body should be washed thoroughly 8-12 hours after application. Adults & children over 2 years: Apply the lotion over the whole body but not the head and face. Pay particular attention to the areas between fingers and toes, under nails, wrists, armpits, external genitalia, breasts and buttocks.

The elderly: Apply the lotion over the whole body including the neck, face, ears and scalp. Pay particular attention to the areas between fingers and toes, under nails, wrists, armpits, external genitalia, breasts and buttocks. Avoid the area close to the eyes.

Children under 2 years: Children under 2 years should only be treated under medical supervision. Apply the lotion over the whole body including the neck, face, ears and scalp. Pay particular attention to the areas between fingers and toes, under nails, wrists, armpits, palms of hands and soles of feet, external genitals and buttocks. Avoid the area around the mouth where the lotion could be licked off and the area around the eyes

Lotion should be applied to clean, dry skin. If the body is hot due to warm bath or any other reason, skin should be allowed to cool. It should be applied to the whole body excluding head. The whole body should be washed thoroughly 8-12 hours after treatment. On the next day cloths and bed sheets should be cleaned with warm water. The lotion should be applied if lotion is washed out by water. Other members of the family should use this lotion as preventive in the same way due to its highly contagious effects. The lotion should not be applied to the vicinity of mouth and areas close to eyes.

Occasional reports of burning or stinging sensation which passes quickly. This is usually mild and occurs more frequently in patients with severe scabies. Transient signs and symptoms of skin irritation including rash or itching, erythema, edema and eczema. These are generally considered to be part of the natural history of scabies.

Combination of permethrin 5% and crotamiton 10% is contra-indicated in patients with known hypersensitivity to permethrin or crotamiton.

This lotion should be kept out of the reach of children. This lotion is for external use only. Nursing staff who routinely apply this lotion may wish to wear gloves to avoid any possible irritation to the hand. Avoid contact with the eyes. The lotion can cause eye irritation. If lotion goes to the eyes, rinse with water immediately.

The treatment of eczematous-like reactions with corticosteroids should be withheld prior to treatment with permethrin, as there is a risk of exacerbating the scabies infestation by reducing the immune response to the mite. The likelihood of interactions between the two treatments leading to potentiated adverse reactions or reduced efficacy is, however small.

There is no experience to judge the safety of permethrin & crotamiton in pregnancy, therefore it is not recommended during pregnancy, especially in the first three months. It is not known whether the active substance passes into breast milk. Nursing mothers should avoid applying it in the area of the nipples.

There are no reports of overdosage of permethrin & crotamiton. Excessive application to the skin might result in local adverse reactions. In the event of accidental ingestion by a child, gastric lavage should be considered if within 2 hours of ingestion. Treatment of hypersensitivity reactions should be symptomatic.

Store in a cool place (do not store above 25° C & do not freeze) and protected from light.

Upadacitinib is a Janus kinase (JAK) inhibitor indicated for the treatment of adults with moderate to severe active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.

Drugs used for Rheumatoid Arthritis

Upadacitinib is a Janus kinase (JAK) inhibitor. JAKs are intracellular enzymes which transmit signals arising from cytokine or growth factor-receptor interactions on the cellular membrane to influence cellular processes of hematopoiesis and immune cell function. Within the signaling pathway, JAKs phosphorylate and activate Signal Transducers and Activators of Transcription (STATs) which modulate intracellular activity including gene expression. Upadacitinib modulates the signaling pathway at the point of JAKs, preventing the phosphorylation and activation of STATs.

The recommended dose of Upadacitinib is 15 mg once daily. Upadacitinib may be used as monotherapy or in combination with methotrexate or other non-biologic DMARDs. Avoid initiation or interrupt Upadacitinib if absolute lymphocyte count is less than 500 cells/mm³, absolute neutrophil count is less than 1000 cells/mm³ or hemoglobin level is less than 8 g/dL.

Pediatric Use: The safety and efficacy of Upadacitinib in children and adolescents aged 0 to 18 years have not yet been established. No data are available.

Adverse reactions (greater than or equal to 1%) are: upper respiratory tract infections, nausea, cough, and pyrexia.

Strong CYP3A4 Inhibitors: Upadacitinib exposure is increased when co-administered with strong CYP3A4 inhibitors (such as ketoconazole). Upadacitinib should be used with caution in patients receiving chronic treatment with strong CYP3A4 inhibitors.

Strong CYP3A4 Inducers: Upadacitinib exposure is decreased when co-administered with strong CYP3A4 inducers (such as rifampin), which may lead to reduced therapeutic effect of Upadacitinib. Coadministration of Upadacitinib with strong CYP3A4 inducers is not recommended.

The limited human data on use of Upadacitinib in pregnant women are not sufficient to evaluate a drug-associated risk for major birth defects or miscarriage. Based on animal studies, upadacitinib has the potential to adversely affect a developing fetus. Advise not to breastfeed.

Upadacitinib was administered in clinical trials up to doses equivalent in daily AUC to 60 mg extended-release once daily. Adverse events were comparable to those seen at lower doses and no specific toxicities were identified. Approximately 90% of upadacitinib in the systemic circulation is eliminated within 24 hours of dosing (within the range of doses evaluated in clinical studies). In case of an overdose, it is recommended that the patient be monitored for signs and symptoms of adverse reactions. Patients who develop adverse reactions should receive appropriate treatment.

Do not store above 25°C. Protect from light. Keep out of reach of children.

Upadacitinib is a Janus kinase (JAK) inhibitor indicated for the treatment of adults with moderate to severe active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.

Drugs used for Rheumatoid Arthritis

Upadacitinib is a Janus kinase (JAK) inhibitor. JAKs are intracellular enzymes which transmit signals arising from cytokine or growth factor-receptor interactions on the cellular membrane to influence cellular processes of hematopoiesis and immune cell function. Within the signaling pathway, JAKs phosphorylate and activate Signal Transducers and Activators of Transcription (STATs) which modulate intracellular activity including gene expression. Upadacitinib modulates the signaling pathway at the point of JAKs, preventing the phosphorylation and activation of STATs.

The recommended dose of Upadacitinib is 15 mg once daily. Upadacitinib may be used as monotherapy or in combination with methotrexate or other non-biologic DMARDs. Avoid initiation or interrupt Upadacitinib if absolute lymphocyte count is less than 500 cells/mm³, absolute neutrophil count is less than 1000 cells/mm³ or hemoglobin level is less than 8 g/dL.

Pediatric Use: The safety and efficacy of Upadacitinib in children and adolescents aged 0 to 18 years have not yet been established. No data are available.

Adverse reactions (greater than or equal to 1%) are: upper respiratory tract infections, nausea, cough, and pyrexia.

Strong CYP3A4 Inhibitors: Upadacitinib exposure is increased when co-administered with strong CYP3A4 inhibitors (such as ketoconazole). Upadacitinib should be used with caution in patients receiving chronic treatment with strong CYP3A4 inhibitors.

Strong CYP3A4 Inducers: Upadacitinib exposure is decreased when co-administered with strong CYP3A4 inducers (such as rifampin), which may lead to reduced therapeutic effect of Upadacitinib. Coadministration of Upadacitinib with strong CYP3A4 inducers is not recommended.

The limited human data on use of Upadacitinib in pregnant women are not sufficient to evaluate a drug-associated risk for major birth defects or miscarriage. Based on animal studies, upadacitinib has the potential to adversely affect a developing fetus. Advise not to breastfeed.

Upadacitinib was administered in clinical trials up to doses equivalent in daily AUC to 60 mg extended-release once daily. Adverse events were comparable to those seen at lower doses and no specific toxicities were identified. Approximately 90% of upadacitinib in the systemic circulation is eliminated within 24 hours of dosing (within the range of doses evaluated in clinical studies). In case of an overdose, it is recommended that the patient be monitored for signs and symptoms of adverse reactions. Patients who develop adverse reactions should receive appropriate treatment.

Do not store above 25°C. Protect from light. Keep out of reach of children.

Armodafinil is indicated to improve wakefulness in adult patients with-

• Obstructive sleep apnea (OSA)
• Narcolepsy
• Shift work disorder (SWD)

CNS stimulant drugs

Armodafinil is an indirect dopamine receptor agonist. This is the R-enantiomer of Modafinil which is a 1:1 mixture of the R- and S-enantiomers. Armodafinil binds to the dopamine transporter and inhibits dopamine reuptake. As a result, increases neuronal activity in the hypothalamus, enhances activity in hypothalamic wakefulness center (TMN, tuberomammillary nucleus) within the hypothalamic sleep wake switch.

Adults:

• Obstructive Sleep Apnea (OSA) & Narcolepsy: 150 mg to 250 mg as a single dose in the morning.
• Shift Work Disorder (SWD): 150 mg as a single dose approximately 1 hour prior to the start of work shift.

Children: Safety and effectiveness in pediatric patients less than 17 years of age have not been established.

Elderly: In elderly patients, elimination of Armodafinil and its metabolites may be reduced as a consequence of aging. Therefore, consideration should be given to the use of lower doses and close monitoring in this population.

The most common side effects of Armodafinil are serious rash, including Stevens-Johnson syndrome, angioedema and anaphylaxis reactions, multi-organ hypersensitivity reactions, persistent sleepiness, psychiatric symptoms and some cardiovascular events.

Contraindicated in patients with known hypersensitivity to Armodafinil or any of theexcipients of this product

Patients should be cautioned about operating an automobile or other hazardous machinery until it is reasonably certain that Armodafinil therapy will not adversely affect their ability to engage in such activities. Caution should be taken in treating patients with a history of psychosis, depression or mania. Discontinuation of treatment should be considered if psychiatric symptoms develop. Increased monitoring of heart rate and blood pressure should be exercised. Caution should be exercised when prescribing Armodafinil to patients with known cardiovascular disease.

The clearance of drugs that are substrates for CYP3A4 or CYP3A5 (e.g., steroidal contraceptives, Cyclosporine, Midazolam and Triazolam) may be increased by Armodafinil which results in lower systemic exposure. Dosage adjustment of these drugs should be considered when used concomitantly with Armodafinil.

Elimination of drugs that are substrates for CYP2C19 (e.g., Phenytoin, Diazepam, Propranolol, Omeprazole and Clomipramine) may be prolonged by Armodafinil which results in higher systemic exposure. Dosage adjustment of these drugs should be considered when used concomitantly with Armodafinil.

More frequent monitoring of prothrombin times/ International normalized ratio (INR) should be considered whenever Armodafinil is co-administered with Warfarin.

Caution should be used when concomitantly administering MAO inhibitors and Armodafinil.

Pregnancy: There are no adequate and well controlled studies of Armodafinil in pregnant women. Armodafinil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation: It is not known whether Armodafinil or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Armodafinil is administered to a nursing woman.

Patients with hepatic impairment: In patients with severe hepatic impairment, Armodafinil should be administered at a reduced dose.

Patients with renal impairment:There is inadequate information to determine safety and efficacy of dosing in patients with severe renal impairment.

There were no overdoses reported in the Armodafinil clinical studies. Symptoms of Armodafinil overdose are likely to be similar to those of Modafinil which included excitation or agitation, insomnia and slight or moderate elevations in hemodynamic parameters. There is no specific antidote for Armodafinil overdose. However, if overdose occurs, it should be managed with primary supportive care.

Store in a cool (below 25°C) and dry place protected from light.

This preparation is indicated in the following cases:

• To relieve discomfort in urinary tract infections
• To prevent kidney stone
• With uricosuric agent to prevent gout
• Acidosis caused by kidney diseases

Prevention of repeated kidney stone formation, Urinary Alkalinizing Agent

Potassium Citrate and Citric Acid oral solution is a stable and pleasant-tasting oral systemic alkalizer. Potassium Citrate is absorbed and metabolized to Potassium Bicarbonate, thus acting as a systemic alkalizer. This product alkalinizes the urine without producing a systemic alkalosis in recommended doses. It is highly palatable, pleasant tasting and tolerable, even when administered for long periods. Potassium Citrate does not neutralize the gastric juice or disturb digestion.

To relieve discomfort in UTI:

• Adults and children over 6 years: 10 ml 3 times daily, diluted with 1 glass of water.
• Children 1-6 years: 5 ml 3 times daily, diluted with ½ glass of water.

To prevent kidney stones, With a uricosuric agent to prevent gout, Acidosis caused by kidney diseases:

• Adults: 10-15 ml 4 times daily (or as directed by the physician) diluted with 1 glass of water.
• Pediatric: 5-10 ml 4 times daily (or as directed by the physician) diluted with ½ glass of water.

This solution is generally well tolerated without any unpleasant side effect when given in recommended doses to patients with normal renal function and urinary output. However, as with any alkalinizing agent, caution must be used in certain patients with abnormal renal mechanisms to avoid development of hyperkalemia or alkalosis. Potassium intoxication causes listlessness, weakness, mental confusion, tingling of extremities and other symptoms associated with a high concentration of Potassium in the serum.

The drug is contraindicated in severe renal impairment with oliguria or azotemia, untreated Addison's disease, acute dehydration, severe myocardial damage and hyperkalemia from any cause.

The solution should be used with caution in patients with low urinary output. It should be diluted adequately with water to minimize the possibility of gastrointestinal injury associated with the oral ingestion of concentrated Potassium salt preparations; and preferably, to take each dose after meals. Large doses may cause hyperkalemia and alkalosis, especially in the presence of renal disease.

Concurrent administration of potassium-containing medication, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors or cardiac glycosides may lead to toxicity.

No information is available regarding the use of this drug during pregnancy and lactation.

The administration of oral Potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired, hyperkalemia can result. Hyperkalemia, when detected, must be treated immediately because lethal levels can be reached in a few hours. If hyperkalemia occurs, treatment measures will include the followings: (1) Elimination of foods or medications containing potassium. (2) The intravenous administration of 300 to 500 ml/hr of dextrose solution (10 to 25%), containing 10 units of insulin/20 gm dextrose. (3) The use of exchange resins, hemodialysis or peritoneal dialysis.

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

Carefully consider the potential benefits and risks of Flurbiprofen and other treatment options before deciding to use Flurbiprofen . Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

Flurbiprofen is indicated:

• For relief of the signs and symptoms of rheumatoid arthritis.
• For relief of the signs and symptoms of osteoarthritis.

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Flurbiprofen inhibits prostaglandin synthesis by decreasing the activity of cyclooxygenase resulting in reduced prostaglandin levels. It is also a potent inhibitor of platelet aggregation.

After observing the response to initial therapy with Flurbiprofen , the dose and frequency should be adjusted to suit an individual patient's needs. For relief of the signs and symptoms of rheumatoid arthritis or osteoarthritis, the recommended starting dose of Flurbiprofen is 200 to 300 mg per day, divided for administration two, three, or four times a day. The largest recommended single dose in a multiple-dose daily regimen is 100 mg.

Should be taken with food.

Oedema, abdominal pain, constipation, diarrhoea, dyspepsia/heartburn, liver enzyme elevations, flatulence, nausea, vomiting, wt change, headache, nervousness, CNS stimulation (e.g. anxiety), CNS inhibition (e.g. somnolence), rhinitis, vision changes, dizziness/vertigo, tinnitus, signs and symptoms of UTI, rash. Ocular hyperaemia, eye irritation, fibrosis, miosis, mydriasis.

Known hypersensitivity to flurbiprofen, history of asthma, urticaria, or allergic-type reactions precipitated by aspirin or other NSAIDs, NSAID-related history of GI bleeding or perforation, treatment of perioperative pain in the setting of CABG surgery. Pregnancy (3rd trimester) and lactation.

Patients with known CV disease or risk factors for CV disease, fluid retention. Hepatic and renal impairment. Lactation.

Reduced antihypertensive effect of ACE inhibitors, angiotensin II receptor antagonists and β-blockers. Slight reduction in blood glucose concentration in patients with DM receiving certain antidiabetic agents (e.g. glyburide, metformin). Reduced diuretic effect of furosemide and thiazides. May increase toxicity of lithium and methotrexate. May increase risk of bleeding with antiplatelets, anticoagulants, SSRIs, corticosteroids.

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.

Symptoms: Headache, nausea, vomiting, epigastric pain, GI bleeding, diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, fainting and occasionally convulsions, acute renal failure and liver damage.

Management: Supportive and symptomatic treatment. Admin activated charcoal w/in 1 hr after ingestion. In adults, gastric lavage should be considered.

Store between 15-25° C.

Active management of the third stage of labour, Treatment and prophylaxis of postpartum haemorrhage, Excessive uterine bleeding, Postpartum and post-abortion bleeding

Drugs acting on the Uterus

Ergometrine causes contraction of the uterine muscle. At low doses, there is an increase in frequency and amplitude of contractions while at higher doses, the basal tone of the uterus is increased. Ergometrine also causes vasoconstriction of peripheral and cerebral vessels.

Intramuscular (Adult)-

• Active management of the third stage of labour: 0.5 mg given with 5 units of oxytocin after delivery of the anterior shoulder of the infant or immediately after delivery.
• Treatment and prophylaxis of postpartum haemorrhage: 0.2 mg, may repeat in severe bleeding every 2-4 hr as needed.

Intravenous (Adult)-

• Excessive uterine bleeding: 0.2 mg via IV inj over at least 1 minute. May follow with oral doses of 0.2 to 0.4 mg 2-4 times daily until the danger of atony or haemorrhage has passed (usually 48 hr).

Oral (Adult)-

• Postpartum and post-abortion bleeding: 0.2 to 0.4 mg 2-4 times daily until danger of uterine atony and haemorrhage has passed (usually 48 hr). Max duration: 1 wk postpartum.

Nausea, vomiting, abdominal pain, diarrhoea; headache, dizziness; tinnitus; chest pain, palpitation, bradycardia, transient hypertension and other cardiac arrhythmias; dyspnoea, sometimes rashes, shock

Pregnancy, 1st and 2nd stage of labour, patients with preeclampsia, eclampsia or threatened spontaneous abortion; porphyria.

Breech and abnormal foetal presentation; hypertension; chronic anaemia; hepatic, renal, respiratory or cardiac impairment; toxemia; lactation; hypocalcaemia. Monitor BP, pulse and uterine response.

Halothane causes relaxation of uterine muscle and may interfere with ergometrine action. Enhanced uterotonic effect with prostaglandins and oxytocin. Concurrent admin with CYP3A4 inhibitors may lead to vasospasm, cerebral ischaemia and/or ischaemia of extremities.

Pregnancy Category X. Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.

Symptoms include peripheral vasoconstriction, encephalopathy, convulsions, respiratory failure, acute renal failure and temporary lactose intolerance. Treatment is supportive.

Intramuscular:  Active management of the third stage of labour: Refrigerate at 2-8°C.
Intravenous:  Refrigerate at 2-8°C.
Oral:  Store below 25°C.

Cranberry is indicated for-

• The treatment and prevention of urinary tract infection.
• Kidney stones.

Herbal and Nutraceuticals

Cranberry (Vaccinium macrocarpon) is a native North American plant commonly used for reduction in urinary tract infections (UTIs) occurrence and kidney stone management. Cranberry reduces the need for repeated antibiotic use in the treatment of recurrent urinary tract infection. Bacterial adherence to mucosal surfaces is generally considered to be the initial event in the pathogenesis of most infectious diseases due to bacteria in human such as UTIs. Cranberry inhibits adherence of bacteria to the lining of the urinary bladder and urethra. At higher dose it also works as a urinary antiseptic and reduces incidence of stone formation. Recent publications show as much as 65% reduction in UTI with cranberry consumption leading to reduced use of antibiotics and reduction in the number of incidences of recurrent cystitis.

1-3 capsules daily or as advised by the physician.

Well tolerated in recommended dose. Occasionally diarrhea or mild gastrointestinal upset may occur at high dose.

Potential contraindications of cranberry may be present with renal insufficiency and in persons with the potential for developing uric acid or calcium oxalate stones.

No known interactions with antibiotics or other drugs. Cranberry enhances vitamin B₁₂ absorption, which is useful for patients taking omeprazole, a drug used to treat ulcers.

No known restrictions during pregnancy or lactation.

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

Tamsulosin Hydrochloride is indicated for the treatment of functional symptoms of Benign Prostatic Hyperplasia (BPH).

BPH/ Urinary retention/ Urinary incontinence

Tamsulosin, a selective alpha1 adrenoceptor blocking agent, exhibits its selectivity for alpha1 A adrenoceptors in human prostate. Blockade of these adrenoceptors can cause smooth muscle in the bladder neck and prostate to relax, resulting in an improvement in urine flow rate and a reduction in symptoms of BPH. Absorption of Tamsulosin hydrochloride capsule 0.4mg is essentially complete (90%) following oral administration under fasting conditions. The time to maximum concentration (Tmax) is reached by four to five hours under fasting conditions and by six to seven hours when administered with food. Tamsulosin hydrochloride is extremely bound to human plasma protein (94% to 99%). Tamsulosin hydrochloride is extensively metabolized by cytochrome P 450 enzymes in the liver and less than 10% of the dose is excreted in urine as unchanged form. Following intravenous or oral administration of an immediate-release formulation the elimination half-life of Tamsulosin hydrochloride in plasma ranges from five to seven hours. Because of the absorption rate controlled pharmacokinetics with Prostam capsules, the apparent half-life of Tamsulosin hydrochloride is approximately 9 to 13 hours in healthy volunteers and 14 to 15 hours in the target population.

Tamsulosin Hydrochloride 0.4 mg (one capsule) daily, to be taken after meal at night. The dose may be increased after 2 to 4 weeks, if necessary, to Tamsulosin Hydrochloride 0.8 mg (two capsules) once daily. If Tamsulosin Hydrochloride administration is discontinued or interrupted for several days at either the 0.4 mg or 0.8 mg dose, therapy should be started again with the Tamsulosin Hydrochloride 0.4 mg (one capsule) once daily dose. The capsule should be swallowed whole with a glass of water (about 150 ml) in the standing or sitting position. The capsule should not be crunched or chewed, as this will interfere with the modified release of the active ingredient.

The following adverse reactions have been reported during the use of Tamsulosin: dizziness, abnormal ejaculation and; less frequently headache, asthenia, postural hypotension and palpitations.

Tamsulosin hydrochloride is contraindicated in patients with hypersensitivity to it; history of orthostatic hypotension; severe hepatic insufficiency.

As with other alpha1 blockers, a reduction in blood pressure can occur in individual cases during treatment with Tamsulosin, as a result of which, rarely, syncope can occur, at the first signs of orthostatic hypotension (dizziness, weakness) the patient should sit or lie down until the symptoms have disappeared. And they should be cautioned to avoid situations where injury could result (like driving, operating machinery or performing hazardous tasks).

Before therapy with Tamsulosin is initiated the patient should be examined in order to exclude the presence of other conditions which can cause the same symptoms as Benign Prostatic hyperplasia. Digital rectal examination and when the necessary determination of Prostate Specific Antigen (PSA) should be performed before treatment and at regular intervals afterwards.

Rarely, transient postural symptoms have occurred during orthostatic provocation testing after the first dose. Use in patients with micturition syncope is not advised.

Effects on ability to drive and use machines: No data is available on whether Tamsulosin adversely affects the ability to drive or operate machines. However, in this respect, patients should be aware of the fact that dizziness can occur.

Concurrent administration of other alfa1-adrenoceptor antagonists could lead to hypotensive effects. No interactions have been seen when Tamsulosin was given concomitantly with either atenolol, enalapril or nifedipine. Concomitant cimetidine brings about a rise and frusemide a fall in plasma levels of Tamsulosin, but as levels remain within the normal range posology need not be changed. No interactions at the level of hepatic metabolism have been seen during in vitro studies with liver microsomal fractions (representative of the cytochrome P450-linked drug-metabolizing enzyme system), involving amitriptyline, salbutamol, glibenclamide, and finasteride. Diclofenac and warfarin, however, may increase the elimination rate of Tamsulosin.

Use of Tamsulosin in pregnancy and lactation is not recommended.

No case of acute overdosage has been reported. However, acute hypotension is likely to occur after overdosage in which case cardiovascular support should be given. Blood pressure can be restored and the heart rate brought back to normal by lying the patient down. If this does not help then volume expanders, and when necessary, vasopressors could be employed. Renal function should be monitored and general supportive measures applied. Dialysis is unlikely to be of help as Tamsulosin is very highly bound to plasma proteins. Measures, such as emesis, can be taken to impede absorption. When large quantities are involved, gastric lavage can be applied and activated charcoal and an osmotic laxative, such as sodium sulphate, can be administered.

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

This is indicated in-

• Dysuria (painful urination)
• Acts as Diuretic
• Renoprotective
• Jaundice & fever

Herbal and Nutraceuticals

Mouri (Foeniculum valgare): It contains Trans-anethole (80-90%), Fenchone (1-10%), Estragole (3-10%), and volatile oil that are used as diuretic, spasmolytic. Dried fruit is useful in chest, spleen & kidney troubles. Oil from seed is used as anti-microbial.

Gohkshura (Tribulus terrestris): It contains saponins, flavone glycosides, alkaloid, fixed oil, potassium nitrate, essential oil & resin that are used in cooling, painful micturition, diuretic, antispasmotic, irritation of urinary organs. It is used as a diuretic in gout, antiseptic, anti-fungal & anti-inflammatory activity. It prevents formation of kidney stone.

Kasni (Cichorium endivia): It contains sesquiterpene lactones, chiroric acid, chlorogenic acid, isochlorogenic acid & dicaffeoyl tartaric acid. It is used as a cooling agent. It is also used fever, headache & jaundice. Root is used as a diuretic and for the treatment of kidney & liver disorders.

Khorbuj (Cucumis melo): It contains ferulic, caffeic, chlorogenic acids & cucurbitacin B & E. It is used as a cooling, nutritive, diuretic. It is used in painful discharge & suppression of urinary infection.

Adult: 2 teaspoonful’s (10 ml) 2-3 times daily.
Children: 1 teaspoonful (5 ml) 2-3 times daily.

There is no significant side effect associated with the use of fennel in the above mentioned therapeutic doses.

There is no absolute contraindication.

Not recommended for use during pregnancy. There is no sufficient information for use in lactation.

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

This preparation is indicated in the following cases:

• To relieve discomfort in urinary tract infections
• To prevent kidney stone
• With uricosuric agent to prevent gout
• Acidosis caused by kidney diseases

Prevention of repeated kidney stone formation, Urinary Alkalinizing Agent

Potassium Citrate and Citric Acid oral solution is a stable and pleasant-tasting oral systemic alkalizer. Potassium Citrate is absorbed and metabolized to Potassium Bicarbonate, thus acting as a systemic alkalizer. This product alkalinizes the urine without producing a systemic alkalosis in recommended doses. It is highly palatable, pleasant tasting and tolerable, even when administered for long periods. Potassium Citrate does not neutralize the gastric juice or disturb digestion.

To relieve discomfort in UTI:

• Adults and children over 6 years: 10 ml 3 times daily, diluted with 1 glass of water.
• Children 1-6 years: 5 ml 3 times daily, diluted with ½ glass of water.

To prevent kidney stones, With a uricosuric agent to prevent gout, Acidosis caused by kidney diseases:

• Adults: 10-15 ml 4 times daily (or as directed by the physician) diluted with 1 glass of water.
• Pediatric: 5-10 ml 4 times daily (or as directed by the physician) diluted with ½ glass of water.

This solution is generally well tolerated without any unpleasant side effect when given in recommended doses to patients with normal renal function and urinary output. However, as with any alkalinizing agent, caution must be used in certain patients with abnormal renal mechanisms to avoid development of hyperkalemia or alkalosis. Potassium intoxication causes listlessness, weakness, mental confusion, tingling of extremities and other symptoms associated with a high concentration of Potassium in the serum.

The drug is contraindicated in severe renal impairment with oliguria or azotemia, untreated Addison's disease, acute dehydration, severe myocardial damage and hyperkalemia from any cause.

The solution should be used with caution in patients with low urinary output. It should be diluted adequately with water to minimize the possibility of gastrointestinal injury associated with the oral ingestion of concentrated Potassium salt preparations; and preferably, to take each dose after meals. Large doses may cause hyperkalemia and alkalosis, especially in the presence of renal disease.

Concurrent administration of potassium-containing medication, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors or cardiac glycosides may lead to toxicity.

No information is available regarding the use of this drug during pregnancy and lactation.

The administration of oral Potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired, hyperkalemia can result. Hyperkalemia, when detected, must be treated immediately because lethal levels can be reached in a few hours. If hyperkalemia occurs, treatment measures will include the followings: (1) Elimination of foods or medications containing potassium. (2) The intravenous administration of 300 to 500 ml/hr of dextrose solution (10 to 25%), containing 10 units of insulin/20 gm dextrose. (3) The use of exchange resins, hemodialysis or peritoneal dialysis.

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

Flavoxate is indicated for symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis and urethrocystitis.

BPH/ Urinary retention/ Urinary incontinence

Flavoxate acts as a direct antagonist at muscarinic acetylcholine receptors in cholinergically innervated organs. Its anticholinergic-parasympatholytic action reduces the tonus of smooth muscle in the bladder, effectively reducing the number of required voids, urge incontinence episodes, urge severity and improving retention, facilitating increased volume per void.

Adults and children over 12 years of age: 100 mg to 200 mg 3 times a day. With improvement of symptoms, the dose may be reduced.

Pediatric Use: Safety and effectiveness in children below the age of 12 years have not been established.

Gastrointestinal: Nausea, vomiting, dry mouth.

CNS: Vertigo, headache, mental confusion, especially in the elderly, drowsiness, nervousness.

Hematologic: Leukopenia (which is reversible upon discontinuation of the drug).

Cardiovascular: Tachycardia and palpitation.

Allergic: Urticaria and other dermatoses, eosinophilia and hyperpyrexia.

Ophthalmic: Increased ocular tension, blurred vision, disturbance in eye accommodation.

Flavoxate is contraindicated in patients who have any of the following obstructive conditions: pyloric or duodenal obstruction, obstructive intestinal lesions or ileus, achalasia, gastrointestinal hemorrhage and obstructive uropathies of the lower urinary tract.

Flavoxate should be given cautiously in patients with suspected glaucoma

Pregnancy: Pregnancy Category B. This drug should be used during pregnancy only if clearly needed.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Caution should be exercised when flavoxate is administered to a nursing woman.

Store Flavoxate at room temperature, between 20 and 25 degrees C

Flavoxate is indicated for symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis and urethrocystitis.

BPH/ Urinary retention/ Urinary incontinence

Flavoxate acts as a direct antagonist at muscarinic acetylcholine receptors in cholinergically innervated organs. Its anticholinergic-parasympatholytic action reduces the tonus of smooth muscle in the bladder, effectively reducing the number of required voids, urge incontinence episodes, urge severity and improving retention, facilitating increased volume per void.

Adults and children over 12 years of age: 100 mg to 200 mg 3 times a day. With improvement of symptoms, the dose may be reduced.

Pediatric Use: Safety and effectiveness in children below the age of 12 years have not been established.

Gastrointestinal: Nausea, vomiting, dry mouth.

CNS: Vertigo, headache, mental confusion, especially in the elderly, drowsiness, nervousness.

Hematologic: Leukopenia (which is reversible upon discontinuation of the drug).

Cardiovascular: Tachycardia and palpitation.

Allergic: Urticaria and other dermatoses, eosinophilia and hyperpyrexia.

Ophthalmic: Increased ocular tension, blurred vision, disturbance in eye accommodation.

Flavoxate is contraindicated in patients who have any of the following obstructive conditions: pyloric or duodenal obstruction, obstructive intestinal lesions or ileus, achalasia, gastrointestinal hemorrhage and obstructive uropathies of the lower urinary tract.

Flavoxate should be given cautiously in patients with suspected glaucoma

Pregnancy: Pregnancy Category B. This drug should be used during pregnancy only if clearly needed.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Caution should be exercised when flavoxate is administered to a nursing woman.

Store Flavoxate at room temperature, between 20 and 25 degrees C

4-Quinolone preparations

Levofloxacin is a synthetic, broad-spectrum, third generation fluoroquinolone antibiotic. Chemically, Levofloxacin is a chiral fluorinated carboxyquinolone. Levofloxacin exerts antibacterial action by inhibiting bacterial topoisomerase IV and DNA gyrase, the enzymes required for DNA replication, transcription repair and recombination. It has in vitro activity against a wide range of gm-ve and gm+ve microorganisms.

The usual dose of Levofloxacin Tablets is 250 mg or 500 mg or 750 mg administered orally every 24 hours. Levofloxacin tablets can be administered without regard to food. Levofloxacin oral solution should be taken 1 hour before, or  2 hours after eating.

Levofloxacin injection should only be administered by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration. The usual dose of Levofloxacin injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours. Since the Levofloxacin injections are for single-use only, any unused portion should be discarded. Additives or other medications should not be added to Levofloxacin Injection or infused simultaneously through the same intravenous line.

Adults:

• Acute sinusitis: 500 mg once daily for 10-14 days, or 750 mg once daily for 5 days
• Exacerbation of chronic bronchitis: 500 mg once daily for 7 days, or 750 mg once daily for 3 days (Uncomplicated), 750 mg once daily for 5 days (Complicated)
• Community-acquired pneumonia: 500 mg once daily for 7-14 days, or 750 mg once daily for 5 days
• Uncomplicated urinary-tract infections: 250 mg once daily for 3 days
• Complicated urinary-tract infections and acute pyelonephritis: 250 mg once daily for 7-10 days
• Uncomplicated skin and soft-tissue infections: 500 mg once daily for 7-10 days.
• Complicated skin and soft-tissue infections: 750 mg once daily for 7-14 days.
• Enteric fever: 500 mg once daily for 7-14 days.
• Diarrhea, cholera, shigellosis & enteritis: Mild to moderate case: 500 mg (single dose). Moderate to sever case: 500 mg once daily for 3 days

Children:

• Children 6 months to <5 years: 10 mg/kg every 12 hours.
• Children >5 years: 10 mg/kg every 24 hours

In each case, sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.

Instructions for the Use of Levofloxacin Infusion-

• Check the container for minute leaks by squeezing the inner bag firmly. If leaks are found, or if the seal is not intact, discard the solution.
• Do not use if the solution is cloudy or a precipitate is present.
• Do not use flexible containers in series connections.
• Close flow control clamp of administration set.
• Remove cover from port at bottom of container.
• Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
• Suspend container from hanger.
• Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Levoxin Injection.
• Open flow control clamp to expel air from set. Close clamp.
• Regulate rate of administration with flow control clamp.

Levofloxacin is generally well tolerated. However, a few side-effects can usually be seen. There is a risk of retinal detachment. Other side-effects include: nausea, vomiting, diarrhea, abdominal pain, flatulence and rare occurrence of phototoxicity (0.1%). Side-effects that may be seen very rarely include tremors, depression, anxiety, confusion etc.

Levofloxacin is contraindicated in patients with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents, or any other components of this product.

The following measures should be taken during administration of Levofloxacin:

• Levofloxacin Injection should only be administered by slow intravenous infusion over a period of 60 or 90 minutes depending on the dosage.
• While administrating Levofloxacin, adequate amount of water should be taken to avoid concentrated form of urine.
• Dose adjustment should be exercised during Levofloxacin administration in presence of renal insufficiency.

No quinolone should be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line. Antacids, Iron and Adsorbents reduce absorption of Levofloxacin. NSAID may increase the risk of CNS stimulation. Warfarin may increase the risk of bleeding.

Levofloxacin is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.

Levofloxacin exhibits a low potential for acute toxicity. However, in the events of an acute overdosage, the stomach should be emptied. The patients should be kept under observation and appropriate hydration should be maintained.

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

4-Quinolone preparations

Levofloxacin is a synthetic, broad-spectrum, third generation fluoroquinolone antibiotic. Chemically, Levofloxacin is a chiral fluorinated carboxyquinolone. Levofloxacin exerts antibacterial action by inhibiting bacterial topoisomerase IV and DNA gyrase, the enzymes required for DNA replication, transcription repair and recombination. It has in vitro activity against a wide range of gm-ve and gm+ve microorganisms.

The usual dose of Levofloxacin Tablets is 250 mg or 500 mg or 750 mg administered orally every 24 hours. Levofloxacin tablets can be administered without regard to food. Levofloxacin oral solution should be taken 1 hour before, or  2 hours after eating.

Levofloxacin injection should only be administered by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration. The usual dose of Levofloxacin injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours. Since the Levofloxacin injections are for single-use only, any unused portion should be discarded. Additives or other medications should not be added to Levofloxacin Injection or infused simultaneously through the same intravenous line.

Adults:

• Acute sinusitis: 500 mg once daily for 10-14 days, or 750 mg once daily for 5 days
• Exacerbation of chronic bronchitis: 500 mg once daily for 7 days, or 750 mg once daily for 3 days (Uncomplicated), 750 mg once daily for 5 days (Complicated)
• Community-acquired pneumonia: 500 mg once daily for 7-14 days, or 750 mg once daily for 5 days
• Uncomplicated urinary-tract infections: 250 mg once daily for 3 days
• Complicated urinary-tract infections and acute pyelonephritis: 250 mg once daily for 7-10 days
• Uncomplicated skin and soft-tissue infections: 500 mg once daily for 7-10 days.
• Complicated skin and soft-tissue infections: 750 mg once daily for 7-14 days.
• Enteric fever: 500 mg once daily for 7-14 days.
• Diarrhea, cholera, shigellosis & enteritis: Mild to moderate case: 500 mg (single dose). Moderate to sever case: 500 mg once daily for 3 days

Children:

• Children 6 months to <5 years: 10 mg/kg every 12 hours.
• Children >5 years: 10 mg/kg every 24 hours

In each case, sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.

Instructions for the Use of Levofloxacin Infusion-

• Check the container for minute leaks by squeezing the inner bag firmly. If leaks are found, or if the seal is not intact, discard the solution.
• Do not use if the solution is cloudy or a precipitate is present.
• Do not use flexible containers in series connections.
• Close flow control clamp of administration set.
• Remove cover from port at bottom of container.
• Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
• Suspend container from hanger.
• Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Levoxin Injection.
• Open flow control clamp to expel air from set. Close clamp.
• Regulate rate of administration with flow control clamp.

Levofloxacin is generally well tolerated. However, a few side-effects can usually be seen. There is a risk of retinal detachment. Other side-effects include: nausea, vomiting, diarrhea, abdominal pain, flatulence and rare occurrence of phototoxicity (0.1%). Side-effects that may be seen very rarely include tremors, depression, anxiety, confusion etc.

Levofloxacin is contraindicated in patients with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents, or any other components of this product.

The following measures should be taken during administration of Levofloxacin:

• Levofloxacin Injection should only be administered by slow intravenous infusion over a period of 60 or 90 minutes depending on the dosage.
• While administrating Levofloxacin, adequate amount of water should be taken to avoid concentrated form of urine.
• Dose adjustment should be exercised during Levofloxacin administration in presence of renal insufficiency.

No quinolone should be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line. Antacids, Iron and Adsorbents reduce absorption of Levofloxacin. NSAID may increase the risk of CNS stimulation. Warfarin may increase the risk of bleeding.

Levofloxacin is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.

Levofloxacin exhibits a low potential for acute toxicity. However, in the events of an acute overdosage, the stomach should be emptied. The patients should be kept under observation and appropriate hydration should be maintained.

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

Prevention of repeated kidney stone formation

When Potassium Citrate is given orally, the metabolism of absorbed citrate produces an alkaline load. The induced alkaline load in turn increases urinary pH and raises urinary citrate by augmenting citrate clearance without measurably altering ultrafilterable serum citrate. Thus, Potassium Citrate therapy appears to increase urinary citrate principally by modifying the renal handling of citrate, rather than by increasing the filtered load of citrate. The increased filtered load of citrate may play some role, however, as in small comparisons of oral citrate and oral bicarbonate, citrate had a greater effect on urinary citrate.

In addition to raising urinary pH and citrate, Potassium Citrate increases urinary potassium by approximately the amount contained in the medication. In some patients, Potassium Citrate causes a transient reduction in urinary calcium.

The changes induced by Potassium Citrate produce urine that is less conducive to the crystallization of stoneforming salts (calcium oxalate, calcium phosphate and uric acid). Increased citrate in the urine, by complexing with calcium, decreases calcium ion activity and thus the saturation of calcium oxalate. Citrate also inhibits the spontaneous nucleation of calcium oxalate and calcium phosphate (brushite).

The increase in urinary pH also decreases calcium ion activity by increasing calcium complexation to dissociated anions. The rise in urinary pH also increases the ionization of uric acid to the more soluble urate ion.

Potassium Citrate therapy does not alter the urinary saturation of calcium phosphate, since the effect of increased citrate complexation of calcium is opposed by the rise in pH-dependent dissociation of phosphate. Calcium phosphate stones are more stable in alkaline urine.

In the setting of normal renal function, the rise in urinary citrate following a single dose begins by the first hour and lasts for 12 hours. With multiple doses the rise in citrate excretion reaches its peak by the third day and averts the normally wide circadian fluctuation in urinary citrate, thus maintaining urinary citrate at a higher, more constant level throughout the day. When the treatment is withdrawn, urinary citrate begins to decline toward the pre-treatment level on the first day.

The rise in citrate excretion is directly dependent on the Potassium Citrate dosage. Following long-term treatment, Potassium Citrate at a dosage of 60 mEq/day raises urinary citrate by approximately 400 mg/day and increases urinary pH by approximately 0.7 units.

In patients with severe renal tubular acidosis or chronic diarrheal syndrome where urinary citrate may be very low (<100 mg/day), Potassium Citrate may be relatively ineffective in raising urinary citrate. A higher dose of Potassium Citrate may therefore be required to produce a satisfactory citraturic response. In patients with renal tubular acidosis in whom urinary pH may be high, Potassium Citrate produces a relatively small rise in urinary pH.

Dosing Instructions: Treatment with extended release potassium citrate should be added to a regimen that limits salt intake (avoidance of foods with high salt content and of added salt at the table) and encourages high fluid intake (urine volume should be at least two liters per day). The objective of treatment with Potassium Citrate is to provide Potassium Citrate in sufficient dosage to restore normal urinary citrate (greater than 320 mg/day and as close to the normal mean of 640 mg/day as possible), and to increase urinary pH to a level of 6.0 or 7.0.

Monitor serum electrolytes (sodium, potassium, chloride and carbon dioxide), serum creatinine and complete blood counts every four months and more frequently in patients with cardiac disease, renal disease or acidosis. Perform electrocardiograms periodically. Treatment should be discontinued if there is hyperkalemia, a significant rise in serum creatinine or a significant fall in blood hemocrit or hemoglobin.

Severe Hypocitraturia: In patients with severe hypocitraturia (urinary citrate <150 mg/day), therapy should be initiated at a dosage of 60 mEq/day (30 mEq two times/day or 20 mEq three times/day with meals or within 30 minutes after meals or bedtime snack). Twenty-four hour urinary citrate and/or urinary pH measurements should be used to determine the adequacy of the initial dosage and to evaluate the effectiveness of any dosage change. In addition, urinary citrate and/or pH should be measured every four months. Doses of Potassium Citrate greater than 100 mEq/day have not been studied and should be avoided.

Mild To Moderate Hypocitraturia: In patients with mild to moderate hypocitraturia (urinary citrate > 150 mg/day) therapy should be initiated at 30 mEq/day (15 mEq two times/day or 10 mEq three times/day within 30 minutes after meals or bedtime snack). Twenty-four hour urinary citrate and/or urinary pH measurements should be used to determine the adequacy of the initial dosage and to evaluate the effectiveness of any dosage change. Doses of Potassium Citrate greater than 100 mEq/day have not been studied and should be avoided.

Nausea, vomiting, diarrhea, and stomach pain may occur. Taking it after meals will help prevent these side effects. An empty tablet shell may appear in your stool. This is harmless because your body has already absorbed the medication.

This drug may cause serious stomach or intestinal problems (e.g., bleeding, blockage, puncture). This medication may cause high potassium levels in the blood (hyperkalemia). A very serious allergic reaction to this drug is rare.

Potassium Citrate is contraindicated:

• In patients with hyperkalemia (or who have conditions pre-disposing them to hyperkalemia), as a further rise in serum potassium concentration may produce cardiac arrest. Such conditions include: chronic renal failure, uncontrolled diabetes mellitus, acute dehydration, strenuous physical exercise in unconditioned individuals, adrenal insufficiency, extensive tissue breakdown or the administration of a potassium-sparing agent (such as triamterene, spironolactone or amiloride).
• In patients in whom there is cause for arrest or delay in tablet passage through the gastrointestinal tract, such as those suffering from delayed gastric emptying, esophageal compression, intestinal obstruction or stricture, or those taking anticholinergic medication.
• In patients with peptic ulcer disease because of its ulcerogenic potential.
• In patients with active urinary tract infection (with either urea-splitting or other organisms, in association with either calcium or struvite stones). The ability of Potassium Citrate to increase urinary citrate may be attenuated by bacterial enzymatic degradation of citrate. Moreover, the rise in urinary pH resulting from Potassium Citrate therapy might promote further bacterial growth.
• In patients with renal insufficiency (glomerular filtration rate of less than 0.7 ml/kg/min), because of the danger of soft tissue calcification and increased risk for the development of hyperkalemia.

This medication should not be used ifpatient have (Addison's disease), current bladder infection, uncontrolled diabetes, severe heart disease (e.g., recent heart attack, heart damage), certain stomach/intestinal problems (diabetic gastroparesis, conditions decreasing gut movement, peptic ulcer, blockage), severe kidney disease (e.g., inability to make urine), potassium-restricted diet, high potassium levels, severe loss of body water (dehydration).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: low calcium levels, severe diarrhea, heart problems (e.g., irregular heartbeat, heart failure), kidney disease, stomach/gut problems (e.g., irritable bowel), severe tissue damage (e.g., severe burns). Before having surgery, tell your doctor or dentist that you are taking this medication.

Pregnancy Category C. Animal reproduction studies have not been conducted. It is also not known whether Potassium Citrate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium Citrate should be given to a pregnant woman only if clearly needed.

Nursing Mothers: The normal potassium ion content of human milk is about 13 mEq/L. It is not known if Potassium Citrate has an effect on this content. Potassium Citrate should be given to a woman who is breast feeding only if clearly needed.

Pediatric Use: Safety and effectiveness in children have not been established.

Treatment Of Overdosage: The administration of potassium salts to persons without predisposing conditions for hyperkalemia rarely causes serious hyperkalemia at recommended dosages. It is important to recognize that hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration and characteristic electrocardiographic changes (peaking of T-wave, loss of P-wave, depression of S-T segment and prolongation of the QT interval). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest.

Treatment measures for hyperkalemia include the following:

• Patients should be closely monitored for arrhythmias and electrolyte changes.
• Elimination of medications containing potassium and of agents with potassium-sparing properties such as potassium-sparing diuretics, ARBs, ACE inhibitors, NSAIDs, certain nutritional supplements and many others.
• Elimination of foods containing high levels of potassium such as almonds, apricots, bananas, beans (lima, pinto, white), cantaloupe, carrot juice (canned), figs, grapefruit juice, halibut, milk, oat bran, potato (with skin), salmon, spinach, tuna and many others.
• Intravenous calcium gluconate if the patient is at no risk or low risk of developing digitalis toxicity.
• Intravenous administration of 300-500 mL/hr of 10% dextrose solution containing 10-20 units of crystalline insulin per 1,000 mL.
• Correction of acidosis, if present, with intravenous sodium bicarbonate.
• Hemodialysis or peritoneal dialysis.
• Exchange resins may be used. However, this measure alone is not sufficient for the acute treatment of hyperkalemia.

Lowering potassium levels too rapidly in patients taking digitalis can produce digitalis toxicity.

This preparation is indicated in the following cases:

• To relieve discomfort in urinary tract infections
• To prevent kidney stone
• With uricosuric agent to prevent gout
• Acidosis caused by kidney diseases

Prevention of repeated kidney stone formation, Urinary Alkalinizing Agent

Potassium Citrate and Citric Acid oral solution is a stable and pleasant-tasting oral systemic alkalizer. Potassium Citrate is absorbed and metabolized to Potassium Bicarbonate, thus acting as a systemic alkalizer. This product alkalinizes the urine without producing a systemic alkalosis in recommended doses. It is highly palatable, pleasant tasting and tolerable, even when administered for long periods. Potassium Citrate does not neutralize the gastric juice or disturb digestion.

To relieve discomfort in UTI:

• Adults and children over 6 years: 10 ml 3 times daily, diluted with 1 glass of water.
• Children 1-6 years: 5 ml 3 times daily, diluted with ½ glass of water.

To prevent kidney stones, With a uricosuric agent to prevent gout, Acidosis caused by kidney diseases:

• Adults: 10-15 ml 4 times daily (or as directed by the physician) diluted with 1 glass of water.
• Pediatric: 5-10 ml 4 times daily (or as directed by the physician) diluted with ½ glass of water.

This solution is generally well tolerated without any unpleasant side effect when given in recommended doses to patients with normal renal function and urinary output. However, as with any alkalinizing agent, caution must be used in certain patients with abnormal renal mechanisms to avoid development of hyperkalemia or alkalosis. Potassium intoxication causes listlessness, weakness, mental confusion, tingling of extremities and other symptoms associated with a high concentration of Potassium in the serum.

The drug is contraindicated in severe renal impairment with oliguria or azotemia, untreated Addison's disease, acute dehydration, severe myocardial damage and hyperkalemia from any cause.

The solution should be used with caution in patients with low urinary output. It should be diluted adequately with water to minimize the possibility of gastrointestinal injury associated with the oral ingestion of concentrated Potassium salt preparations; and preferably, to take each dose after meals. Large doses may cause hyperkalemia and alkalosis, especially in the presence of renal disease.

Concurrent administration of potassium-containing medication, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors or cardiac glycosides may lead to toxicity.

No information is available regarding the use of this drug during pregnancy and lactation.

The administration of oral Potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired, hyperkalemia can result. Hyperkalemia, when detected, must be treated immediately because lethal levels can be reached in a few hours. If hyperkalemia occurs, treatment measures will include the followings: (1) Elimination of foods or medications containing potassium. (2) The intravenous administration of 300 to 500 ml/hr of dextrose solution (10 to 25%), containing 10 units of insulin/20 gm dextrose. (3) The use of exchange resins, hemodialysis or peritoneal dialysis.

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

Bumetanide is indicated for the treatment of edema associated with- Congestive heart failure, Hepatic ascites and, Renal disease including the nephrotic syndrome

Loop diuretics

Bumetanide is a loop diuretic of the sulfamyl category to treat heart failure. It is often used in patients in whom high doses of furosemide are ineffective. There is however no reason not to use bumetanide as a first choice drug. The main difference between the two substances is in bioavailability. It is said to be a more predictable diuretic, meaning that the predictable absorption is reflected in a more predictable effect. Bumetanide is 40 times more potent than furosemide (for patients with normal renal function).

Bumetanide interferes with renal cAMP and/or inhibits the sodium-potassium ATPase pump. Bumetanide appears to block the active reabsorption of chloride and possibly sodium in the ascending loop of Henle, altering electrolyte transfer in the proximal tubule. This results in excretion of sodium, chloride, and water and, hence, diuresis.

Oral: 1 mg in the morning , repeated after 6-8 hours if necessary, In severe cases , 5 mg daily increased by 5 mg every 12-24 hours according to response. Elderly , 500 micrograms daily may be sufficient.

Parenteral:

• By IV Injection: 1-2 mg, repeated after 20 minutes if necessary. Elderly, 500 micrograms (1 ml of Bumetanide) daily may be sufficient.
• By IV Infusion: 2-5 mg over 30-60 minutes.Elderly, 500 micrograms (1 ml of Bumetanide) daily may be sufficient.
• By IM Injection: 1 mg initially then adjusted according to response , Elderly 500 micrograms (1 ml of Bumetanide) daily may be sufficient.

The side effects of Bumetanide include: headache, dizziness, fatigue, postural hypotension and gastrointestinal symptoms. Various skin reactions, photosensitivity reactions and metabolic disturbances, including reduced glucose tolerance are less frequent. Electrolyte disturbances can occur especially during long term treatment.

Loop diuretics should be avoided in severe hypokalaemia, severe hyponatraemia, anuria, comatose and precomatose states associated with liver cirrhosis and in renal failure.

Serum potassium should be measured periodically and potassium supplements or potassium sparing diuretics added if necessary.

Concomitant use of Bumetanide may potentiate the effects of antihypertensive drugs. It shows a tendency to increase the excretion of potassium which can lead to an increase in the sensitivity of the myocardium to the toxic effects of digitalis. As with other diuretics, Bumetanide may cause an increase in blood uric acid.

Pregnancy Category C. There are no adequate and well controlled studies in pregnant woman. It is not known wheather this drug is excreted in human milk.

Paediatric use: Safety and effectiveness in paediatric patients below the age of 18 have not been established.

Symptoms would be those caused by excessive diuresis. Empty stomach by gastric lavage or emesis.

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