Orion Pharma Ltd.

Novelta 480 mg+20 mgThis is indicated to relieve symptoms of dyspepsia, heartburn, acid indigestion, sour stomach, gastroesophageal reflux and hiatal hernia. It is also prescribed in hyperacidity associated with peptic ulcers, gastritis and esophagitis. Magaldrate may be given to children if necessary. Also indicated for the relief of flatulence, abdominal distension and windy colic.Theropeutic ClassAntacids, Anti-dyspeptic/CarminativesPharmacologyMagaldrate neutralizes gastric acid, thereby increasing pH of stomach and duodenal bulb. It also increases lower esophageal sphincter tone and inhibits smooth muscle contraction and gastric emptying. Simethicone lowers the surface tension of gas bubbles.Dosage & Administration of Novelta 480 mg+20 mgTablet: 1-4 chewable tablets, 20 to 60 minutes after meals and at bedtime, or as directed by the physician.Suspension: 2-4 teaspoonfuls (10-20 ml) of suspension, 20 to 60 minutes after meals and at bed time, or as directed by the physician.Dosage of Novelta 480 mg+20 mgTablet: 1-4 chewable tablets, 20 to 60 minutes after meals and at bedtime, or as directed by the physician.Suspension: 2-4 teaspoonfuls (10-20 ml) of suspension, 20 to 60 minutes after meals and at bed time, or as directed by the physician.Interaction of Novelta 480 mg+20 mgIt should not be used in patients taking any form of Tetracycline. The drug may cause reduced bio-availability or slower absorption of a number of drugs including propranolol, isoniazid, prednisolone and naproxen.ContraindicationsMagaldrate is contraindicated in patients with known hypersensitivity to magnesium and aluminium. It is also contraindicated in patients with impaired renal functions.Side Effects of Novelta 480 mg+20 mgGastrointestinal side-effects are uncommon. Occasionally, if excessive amount is consumed, diarrhea, constipation or regurgitation may occur.Pregnancy & LactationPregnancy category C. So should be used in pregnancy only when necessary. Chronic high dose should be avoided.Precautions & WarningsCare should be taken in decreased kidney function, hypophosphataemia and weak people.Overdose Effects of Novelta 480 mg+20 mgOver dosage with this formulation is a rare case.Storage ConditionsKeep below 30?C temperature, away from light & moisture. Keep out of the reach of children.Use In Special PopulationsChildren: Not recommended under 6 years of age unless properly diagnosed.Drug ClassesAntacids, Anti-dyspeptic/CarminativesMode Of ActionThis is a combination of magaldrate and simethicone. Magaldrate (magnesium aluminium compound i.e. Hydroxymagnesium Aluminate), which neutralizes gastric acid extraordinarily quickly without raising the pH above 5-6. It also decreases the activity of pepsin in gastric secretion. Besides this, simethicone, the another component of Marlox Plus, enables the gas buble to coalesce and give relief from flatulence.PregnancyMagaldrate may be used in pregnancy if indicated however one should avoid excessive dosage. Magaldrate may pass into breast milk but has not been reported to cause problem in nursing babies.

Oclazid MR 30 mgOclazid MR 30 mg is a medicine that reduces blood sugar levels (oral antidiabetic medicine belonging to the sulphonylurea group). Oclazid MR 30 mg is used in a certain form of diabetes (type 2 diabetes Mellitus) in adults, when diet, exercise and weight loss alone do not have an adequate effect on keeping blood sugar at the correct level.Theropeutic ClassSulfonylureasPharmacologyOclazid MR 30 mg is a second generation sulfonylurea drug that has hypoglycaemic and potentially useful haemobiological properties. It stimulates the release of insulin from pancreatic ?-cells by facilitating Ca2+ transport across the ?-cell membranes and decreases hepatic glucose output.Dosage & Administration of Oclazid MR 30 mgOral route: The usual initial dose is 40 to 80 mg daily. The dose can be increased upto 320 mg daily in divided doses when needed. The drug should be taken before meal. For children Oclazid MR 30 mg is not used because it is contraindicated in juvenile- onset diabetes.Dosage of Oclazid MR 30 mgFilm-coated tablet: The usual initial dose is 40 to 80 mg daily. The dose can be increased up to 320 mg daily in divided doses when needed. The drug should be taken before meal. For children, Oclazid MR 30 mg is not used because it is contraindicated in juvenile-onset diabetes.Modified release preparation: Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The dose is determined by the doctor, depending on your blood and possibly urine sugar levels. Change in external factors (weight reduction, lifestyle, stress) or improvements in the blood sugar control may require changed Oclazid MR 30 mg doses.The recommended daily dose is one to four tablets (maximum 120 mg) in a single intake at breakfast time. This depends on the response to treatment. Oclazid MR 30 mg MR tablet is for oral use. Take your tablet(s) with a glass of water at breakfast time (and preferably at the same time each day). Swallow your whole tablet(s) in one piece. Do not chew or crush. You must always eat a meal after taking your tablet(s).If a combination therapy of Oclazid MR 30 mg with metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor a GLP-1 receptor agonist or insulin is initiated your doctor will determine the proper dose of each medicine individually for you. If you notice that your blood sugar levels are high although you are taking the medicine as prescribed, you should contact your doctor or pharmacist.If you take more Oclazid MR 30 mg tablets than you should: If you take too many tablets, contact your doctor or the nearest hospital Accident & Emergency department immediately. The signs of overdose are those of low blood sugar (hypoglycaemia). The symptoms can be helped by taking sugar (4 to 6 lumps) or sugary drinks straight away, followed by a substantial snack or meal. If the patient is unconscious immediately inform a doctor and call the emergency services. The same should be done if somebody, (for instance a child), has taken the product unintentionally. Unconscious patients must not be given food or drink. It should be ensured that there is always a pre-informed person that can call a doctor in case of emergency.If you forget to take Oclazid MR 30 mg tablet: It is important to take your medicine every day as regular treatment works better. However, if you forget to take a dose of Oclazid MR 30 mg MR tablet, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.If you stop taking Oclazid MR 30 mg MR tablet: As the treatment for diabetes is usually lifelong, you should discuss with your doctor before stopping this medicinal product. Stopping could cause high blood sugar (hyperglycaemia) which increases the risk of developing complications of diabetes. If you have any further questions on the use of this product, ask your doctor or pharmacist.Interaction of Oclazid MR 30 mgOther medicines and Oclazid MR 30 mg: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. The blood sugar lowering effect of Oclazid MR 30 mg may be strengthened and signs of low blood sugar levels may occur when one of the follow ng medicines is taken: other medicines used to treat high blood sugar (oral antidiabetics, GLP-1 receptor agonists or insulin), antibiotics (sulphonamides, clarithromycin) medicines to treat high blood pressure or heart failure (beta-blockers. ACE-inhibitors such as captopril, or enalapril) medicines to treat fungal infections (miconazole, fluconazole) medicines to treat ulcers in the stomach or duodenum (H2 receptor antagonists), medicines to treat depression (monoamine oxidase inhibitors) painkiller or antirheumatics (phenylbutazone, ibuprofen) medicines containing alcohol The blood-glucose-lowering effect of Oclazid MR 30 mg may be weakened and raised blood sugar levels may occur when one of the following medicines is taken: medicines to treat disorders of the central nervous system (chlorpromazine) medicines reducing inflammation (corticosteroids) medicines to treat asthma or used during labour (intravenous salbutamol, ritodrine and terbutaline) medicines to treat breast disorders, heavy menstrual bleeding and endometriosis (danazol) St John's Wort- Hypericum perforatum- preparations Blood glucose disturbance (low blood sugar and high blood sugar) can occur when a medicine belonging to a class of antibiotics called fluoroquinolones is taken at the same time as Oclazid MR 30 mg especially in elderly patients.Oclazid MR 30 mg may increase the effects of medicines that reduce blood clotting (warfarin). Consult your doctor before you start taking another medicinal product. If you go into hospital tell the medical staff you are taking Oclazid MR 30 mg.Oclazid MR 30 mg with food and drink: Oclazid MR 30 mg can be taken with food and non-alcoholic drinks. Drinking alcohol is not recommended as it can alter the control of your diabetes in an unpredictable manner.Driving and using machines: Your ability to concentrate or react may be impaired if your blood sugar is too low (hypoglycaemia), or too high (hyperglycaemia) or if you develop visual problems as a result of such conditions. Bear in mind that you could endanger yourself or others (for instance when driving a car or using machines). Please ask your doctor whether you can drive a car if you: have frequent episodes of low blood sugar (hypoglycaemia) have few or no warning signals of low blood sugar (hypoglycaemia) Oclazid MR 30 mg contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.ContraindicationsDo not take Oclazid MR 30 mg: if you are allergic to Oclazid MR 30 mg or to other medicines of the same group (sulfonylurea), or to other related medicines (hypoglycaemic sulfonamides) if you have insulin-dependent diabetes (type 1) if you have ketone bodies and sugar in your urine (this may mean you have diabetic ketoacidosis), a diabetic pre-coma or coma if you have severe kidney or liver disease if you are taking medicines to treat fungal infections if you are breastfeeding Side Effects of Oclazid MR 30 mgLike all medicines, Oclazid MR 30 mg can cause side effects, although not everybody gets them. The most commonly observed side effect is low blood sugar (hypoglycaemia). If left untreated these symptoms could progress to drowsiness, loss of consciousness or possibly coma. If an episode of low blood sugar is severe or prolonged, even if it is temporarily controlled by eating sugar, you should seek immediate medical attention.Liver disorders: There have been isolated reports of abnormal iiver function, which can cause yellow skin and eyes. If you get this, see your doctor immediately. The symptoms generally disappear if the medicine is stopped. Your doctor will decide whether to stop your treatment.Skin disorders: Skin reactions such as rash, redness, itching, hives, blisters, angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may result in breathing difficulty) have been reported. Rash may progress to widespread blistering or peeling of the skin. If you develop this, stop taking, seek urgent advice from a doctor and tell him that you are taking this medicine. Exceptionally, signs of severe hypersensitivity reactions have been reported: initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature.Blood disorders: Decrease in the number of cells in the blood (e.g. platelets, red and white blood cells) which may cause paleness, prolonged bleeding, bruising, sore throat and fever have been reported. These symptoms usually vanish when the treatment is discontinued.Digestive disorders: Abdominal pain, nausea, vomiting, indigestion, diarrhoea, and constipation. These effects are reduced when Oclazid MR 30 mg is taken with a meal as recommended.Eye disorders: Your vision may be affected for a short time especially at the start of treatment. This effect is due to changes in blood sugar levels. As for another sulfonylurea, the following adverse events have been observed: cases of severe changes in the number of blood cells and allergic inflammation of the wall of blood vessels, reduction in blood sodium (hyponatraemia), symptoms of liver impairment (for instance jaundice) which in most cases disappeared after withdrawal of the sulfonylurea, but may lead to life-threatening liver failure in isolated cases.Reporting of side effects: If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information on the safety of this medicine.Pregnancy & LactationOclazid MR 30 mg is contraindicated in pregnant women. It should not be used in breast feeding mother.Precautions & WarningsTalk to your doctor before taking Oclazid MR 30 mg. You should observe the treatment plan prescribed by your doctor to achieve proper blood sugar levels. This means, apart from regular tablet intake, to observe the dietary regimen, have physical exercise and, where necessary, reduce weight During Oclazid MR 30 mg treatment regular monitoring of your blood (and possibly urine) sugar level and also your glycated haemoglobin (HbA1c) is necessary. In the first few weeks of treatment, the risk of having reduced blood sugar levels (hypoglycaemia) may be increased. So particularly close medical monitoring is necessary.Low blood sugar (Hypoglycaemia) may occur: if you take meals irregularly or skip meals altogether, if you are fasting if you are malnourished if you change your diet if you increase your physical activity and carbohydrate intake does not match this increase, if you drink alcohol, especially in combination with skipped meals, if you take other medicines or natural remedies at the same time, if you take too high doses of Oclazid MR 30 mg, if you suffer from particular hormone-induced disorders (functional disorders of the thyroid gland, pituitary gland or adrenal cortex), if your kidney function or liver function is severely decreased. if you have low blood sugar you may have the following symptoms: headache, intense hunger, nausea, vomiting, weariness, sleep disorders, restlessness, aggressiveness, poor concentration, reduced alertness and reaction time, depression, confusion, speech or visual disorders, tremor, sensory disturbances, dizziness and helplessness.The following signs and symptoms may also occur: sweating, clammy skin, anxiety, fast or irregular heartbeat, high blood pressure, sudden strong pain in the chest that may radiate into nearby areas (angina pectoris).If blood sugar levels continue to drop you may suffer from considerable confusion (delirium), develop convulsions, lose self-control, your breathing may be shallow and your heartbeat slowed down, you may become unconscious.In most cases the symptoms of low blood sugar vanish very quickly when you consume .some form of sugar, (for instance, glucose tablets, sugar cubes, sweet juice, sweetened tea).You should therefore always carry some form of sugar with you (glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective. Please contact your doctor or the nearest hospital if taking sugar does not help or if the symptoms recur.Symptoms of low blood sugar may be absent, less obvious or develop very slowly or you are not aware in time that your blood sugar level has dropped. This may happen if you are an elderly patient taking certain medicines (for instance those acting on the central nervous system and beta-blockers).If you are in stressful situations (e.g. accidents, surgical operations, fever etc.) your doctor may temporarily switch you to insulin therapy.Symptoms of high blood sugar (hyperglycaemia) may occur when Oclazid MR 30 mg has not yet sufficiently reduced the blood sugar when you have not complied with the treatment plan prescribed by your doctor if you take St. John?s Wort (Hypericum perforatum) preparations or in special stress situations. These may include thirst, frequent urination, dry mouth, dry itchy skin, skin infections and reduced performance.Blood glucose disturbances (low blood sugar and high bold sugar) can occur when Oclazid MR 30 mg is prescribed at the same time as medicines to a class of antibiotics called fluoroquinolone, especially in elderly patients. In this case, your doctor will remind you of the importance of monitoring your blood glucose.If you have a family history of or know you have the hereditary condition glucose-6-phosphate dehydrogenase (G6PD) deficiency (abnormality of red blood cells), lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anaemia) can occur. Contact your doctor before taking this medicinal product.Oclazid MR 30 mg is not recommended for use in children due to lack of data.Storage ConditionsKeep out of the reach and sight of children. Do not use this medicine after the expiry date which is stated on the carton and the blister. The expiry date refers to the last day of that month. Store below 30?C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.Drug ClassesSulfonylureasMode Of ActionOclazid MR 30 mg is a second generation sulfonylurea drug that has hypoglycaemic and potentially useful hematological properties. It stimulates the release of insulin from pancreatic ?-cells by facilitating Ca+2? transport across the ?-cell membranes and decreases hepatic glucose output.PregnancyOclazid MR 30 mg is not recommended for use during pregnancy. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. You must not take Oclazid MR 30 mg while you are breastfeeding.

Olmesafe-HT 20 mg+12.5 mgOlmesartan Medoxomil & Hydrochlorothiazide combination is indicated for the treatment of hypertension.Theropeutic ClassCombined antihypertensive preparationsPharmacologyHydrochlorothiazide inhibits the reabsorption of Na in the distal tubules causing increased excretion of Na and water including K and hydrogen ions.Olmesartan blocks the vasoconstrictor effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in vascular smooth muscle. Its action is therefore independent of the pathways for angiotensin II synthesis.An AT2 receptor is also found in many tissues, but this receptor is not known to be associated with cardiovascular homeostasis. Olmesartan has more than a 12,500-fold greater affinity for the AT1 receptor than for the AT2 receptor.?Blockade of the renin-angiotensin system with ACE inhibitors, which inhibit the biosynthesis of angiotensin II from angiotensin I, is a mechanism of many drugs used to treat hypertension. ACE inhibitors also inhibit the degradation of bradykinin, a reaction also catalyzed by ACE. Because olmesartan medoxomil does not inhibit ACE, it does not affect the response to bradykinin. Whether this difference has clinical relevance is not yet known.Blockade of the angiotensin II receptor inhibits the negative regulatory feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and circulating angiotensin II levels do not overcome the effect of olmesartan on blood pressure.Dosage & Administration of Olmesafe-HT 20 mg+12.5 mgThe usual recommended starting dose of Olmesartan Medoxomil is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose may be increased to 40 mg. No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance30 ml/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so this combination tablet is not recommended.Patients with Hepatic Impairment:?No dosage adjustment is necessary with hepatic impairment.Paediatric population: The safety and efficacy of Olmesartan & Hydrochlorothiazide in children and adolescents below 18 years has not been established. No data are available.Drug ClassesCombined antihypertensive preparationsMode Of ActionAngiotensin-II formed from angiotensin-I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Olmesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin-II by selectively blocking the binding of angiotensin-II to the AT 1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland). In-vitro-binding studies indicate that Olmesartan is a reversible & competitive inhibitor of AT 1 receptor. Olmesartan does not inhibit ACE (kinase-I, the enzyme that converts angiotensin-I to angiotensin-II and degrades bradykinin).Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing the excretion of Sodium and Chloride in approximately equivalent amounts. Indirectly, the diuretic action of Hydrochlorothiazide reduces plasma volume with consequent increases in plasma renin activity, increases Aldosterone secretion & urinary Potassium loss and decreases serum Potassium. The renin-aldosterone link is mediated by angiotensin-II. So, co-administration of an angiotensin-II receptor antagonist tends to reverse the potassium loss associated with these diuretics.PregnancySafety and effectiveness in nursing mother & pregnancy have not been established. The drug should be discontinued during these conditions.Pediatric UsesRenal Impairment Patients: The usual regimens of therapy with this may be followed provided the patient's creatinine clearance is >30 ml/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides. So, this preparation is not recommended.Hepatic Impairment Patients: No dosage adjustment is necessary with hepatic impairment.Paediatric use: Safety and effectiveness in paediatric patients have not been established.Geriatric use: Clinical studies of Olmesartan and Hydrochlorothiazide combination did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious.

Olmesafe 20 mgOlmesafe 20 mg is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.Theropeutic ClassAngiotensin-ll receptor blockerPharmacologyOlmesartan medoxomil is a potent, orally active, selective angiotensin II receptor (type AT1) antagonist. It is expected to block all actions of angiotensin II mediated by the AT1 receptor, regardless of the source or route of synthesis of angiotensin II. The selective antagonism of the angiotensin II (AT1) receptors results in increases in plasma renin levels and angiotensin I and II concentrations, and some decrease in plasma aldosterone concentrations. Angiotensin II is the primary vasoactive hormone of the renin-angiotensin- aldosterone system (RAAS) and plays a significant role in the pathophysiology of hypertension via the type 1 (AT1) receptor.Dosage & Administration of Olmesafe 20 mgAdult:?Dosage must be individualized. The usual initial dose is 10 mg once daily. In patients whose blood pressure is not adequately controlled at this dose, the dose may be increased to 20 mg once daily as the optimal dose. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Olmesartan may be increased to 40 mg. Doses above 40 mg do not appear to have greater effect.Pediatric Use: Safety and effectiveness in pediatric patients have not been established.Geriatric Use: Of the total number of hypertensive patients receiving Olmesafe 20 mg in clinical studies, more than 20% were 65 years of age and over, while more than 5% were 75 years of age and older. No overall differences in effectiveness or safety were observed between elderly patients and younger patients.Dosage of Olmesafe 20 mgDosage must be individualized. The usual recommended starting dose of Olmesartan is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Olmesartan may be increased to 40 mg. Doses above 40 mg do not appear to have a greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily. No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40 ml/min) or with moderate to marked hepatic dysfunction. For patients with possible depletion of intravascular volume (e.g. patients treated with diuretics, particularly those with impaired renal function), Olmesartan should be initiated under close medical supervision and consideration should be given to use of a lower starting dose. Olmesartan may be administered with or without food.Interaction of Olmesafe 20 mgWith medicine: No significant drug interactions were reported in which Olmesartan was co-administered.With food & others: Food does not affect the bioavailability of Olmesartan.ContraindicationsOlmesartan is contraindicated in patients who are hypersensitive to any component of this product.Side Effects of Olmesafe 20 mgCommon: The most common side effects include Back pain, bronchitis, creatine phosphokinase increased, diarrhea, headache, hematuria, hyperglycemia, hypertriglyceridemia, influenza-like symptoms, pharyngitis, rhinitis, and sinusitis.Rare: Chest pain, peripheral edema, arthritis.Pregnancy & LactationPregnancy Categories?C (first trimester) and D (second and third trimesters).Nursing Mothers: It is not known whether Olmesartan is excreted in human milk, but Olmesartan is secreted at low concentration in the milk of lactating rats. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.Precautions & WarningsAs a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals treated with Olmesafe 20 mg. In patients whose renal function may depend upon the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure), treatment with angiotensin-converting enzyme inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Similar results may be anticipated in patients treated with Olmesafe 20 mg.Overdose Effects of Olmesafe 20 mgSymptoms: There is no experience of overdose with Olmesartan. The most likely effects of Olmesafe 20 mg overdosage are hypotension and tachycardia; bradycardia could be encountered if parasympathetic (vagal) stimulation occurred.Treatment: If intake is recent, gastric lavage or induction of emesis may be considered. Clinically significant hypotension due to an overdose of Olmesartan requires the active support of the cardiovascular system, including close monitoring of heart and lung function, the elevation of the extremities, and attention to circulating fluid volume and urine output.Storage ConditionsStore in cool & dry place below 30?C, protect from light & moisture. Keep out of the reach of children.Use In Special PopulationsHepatic Impairment: Dose should not exceed 20 mg daily in moderate impairment.Renal Impairment: Max. 20 mg daily if eGFR 20?60 mL/minute/1.73 m2. Avoid if eGFR less than 20 mL/minute/1.73 m2.Drug ClassesAngiotensin-ll receptor blockerMode Of ActionAngiotensin-II formed from angiotensin-I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Olmesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin-II by selectively blocking the binding of angiotensin-II to the AT 1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland). In-vitro-binding studies indicate that Olmesartan is a reversible & competitive inhibitor of AT 1 receptor. Olmesartan does not inhibit ACE (kinase-I, the enzyme that converts angiotensin-I to angiotensin-II and degrades bradykinin).PregnancyPregnancy: When pregnancy is detected, discontinue this product as soon as possible. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.Nursing Mothers: It is not known whether Olmesartan is excreted in human milk, but Olmesartan is secreted at low concentration in the milk of lactating rats. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.Pediatric UsesPaediatric use: Safety and effectiveness in paediatric patients have not been established.

Palostar 0.5 mgPalostar 0.5 mg indicated in- Acute and delayed nausea and vomiting Uncontrolled nausea and vomiting Chemotherapy-induced nausea and vomiting (CINV): Acute CINV resulting in on the day of treatment with certain types of chemotherapy Delayed CINV resulting in on days later with certain types of chemotherapy ... Read morePalostar 0.5 mg indicated in- Acute and delayed nausea and vomiting Uncontrolled nausea and vomiting Chemotherapy-induced nausea and vomiting (CINV): Acute CINV resulting in on the day of treatment with certain types of chemotherapy Delayed CINV resulting in on days later with certain types of chemotherapy Radiotherapy-induced nausea and vomiting (RINV) Post-operative & Post-discharge nausea and vomiting (PONV & PDNV). Theropeutic ClassAnti-emetic drugsPharmacologyNausea and Vomiting is usually produced by chemotherapeutic agents by releasing serotonin from the enterochromaffin cells of the small intestine.The released serotonin (5-HT) then activates 5-HT3 receptors located on vagal afferents to initiate the vomiting reflex. Postoperative nausea and vomiting is influenced by multiple patient, surgical and anesthesia related factors and is triggered by release of serotonin (5-HT) in a cascade of neuronal events involving both the central nervous system and the gastrointestinal tract. The 5-HT3 receptor has been demonstrated to selectively participate in the emetic response. Palostar 0.5 mg is a 5-HT3 receptor antagonist with a strong binding affinity for this receptor and little or no affinity for other receptors. So by binding with this receptor Palostar 0.5 mg inhibits binding of serotonine to this receptor and also inhibits vomiting reflux.Dosage of Palostar 0.5 mgUsual dosage: Adult tablet dosage: 0.5 mg daily. Adult IV dosage: A single IV dose of 0.075 mg should be administered over 10 seconds.Chemotherapy-induced nausea and vomiting: Adult tablet dosage: 0.5 mg administered approximately 1 hour prior to the start of chemotherapy. Adult IV dosage: A single IV dose of 0.25 mg should be administered over 30 seconds approximately 30 minutes before the start of chemotherapy.Radiotherapy-induced nausea and vomiting: A single IV dose of 0.25 mg should be administered over 30 seconds approximately 30 minutes before each week of radiation fraction.Post-operative nausea and vomiting: A single IV dose of 0.075 mg should be administered over 10 seconds immediately before induction of anesthesia.Children dosage: (1 month to 17 years): A single IV dose at 20 mcg/kg body weight. Which maximum dose is 1.5 mg.Administration of Palostar 0.5 mgInstructions for I.V. Administration- It should not be mixed with other drugs Flush the infusion line with normal saline before and after administration Parenteral drug products should be inspected visually for particulate matter and discoloration before administration Interaction of Palostar 0.5 mgIn controlled clinical trials, Palostar 0.5 mg injection has been safely administered with corticosteroids, analgesics, antiemetics/antinauseants, antispasmodics and anticholinergic agents. Palostar 0.5 mg did not inhibit the antitumor activity of cisplatin, cyclophosphamide, cytarabine, doxorubicin and mitomycin C in murine tumor models. Concomitant administration of Palostar 0.5 mg and metoclopramide has no significant pharmacokinetic interactions. In vitro studies indicated that Palostar 0.5 mg is not inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2D6, CYP2E1 & CYP3A4/5 (CYP2C19 was not investigated) nor does it induce the activity of CYP1A2, CYP2D6 or CYP3A4/5. Therefore, the potential for clinically significant drug interactions with Palostar 0.5 mg appears to be low.ContraindicationsPalostar 0.5 mg is contraindicated in patients known to have hypersensitivity to the drug or any of its components.Side Effects of Palostar 0.5 mgThe most common adverse reactions are headaches and constipation.Pregnancy & LactationUS FDA Pregnancy category B. It is not known whether Paloxiron is excreted in human milk.Precautions & Warnings For IV administration only. Not for intradermal, subcutaneous, or IM administration. Do not administer if particulate matter, cloudiness, or discoloration is noted. Discard any unused solution. Do not save unused solution for later administration. Do not mix with other medications. Overdose Effects of Palostar 0.5 mgThere is no known antidote to Palostar 0.5 mg. Overdose should be managed with supportive care.Storage ConditionsStore in a cool & dry place, protected from light.Use In Special PopulationsPediatric Use: Safety and effectiveness in patients below the age of 18 years have not been established. However different clinical trial shows Palostar 0.5 mg is well tolerated and effective from one month of age.Geriatric Use: Pharmacokinetics analysis did not reveal any differences in Palostar 0.5 mg pharmacokinetics between patients ? 65 years of age and younger patients (18 to 64 years)Renal Function Impairment: No dosage adjustments are needed with any degree of renal function impairment.Hepatic Function Impairment: No dosage adjustments are needed with any degree of hepatic function impairment.Elderly: No dosage adjustments or special monitoring are needed in elderly patients.ReconstitutionIntravenous: Nausea and vomiting associated with cancer chemotherapy: Physically and chemically stable at concentrations of 5 and 30 mcg/ml in glucose 5%, sodium chloride 0.9%, glucose 5% in lactated Ringer's for at least 48 hr at room temperature, exposed to light and for 14 days under refridgeration.Drug ClassesAnti-emetic drugsMode Of ActionPalostar 0.5 mg is a 5-HT3 receptor antagonist with a strong binding affinity for this receptor and little or no affinity for other receptors. It is thought that chemotherapeutic agents produce nausea and vomiting by releasing serotonin from the enterochromaffin cells of the small intestine and that the released serotonin then activates 5-HT3 receptors that are located on the nerve terminals of the vagus in the periphery and centrally in the chemoreceptor trigger zone of the area postrema, to initiate the vomiting reflex. Postoperative nausea and vomiting is influenced by multiple patient, surgical and anesthesia related factorcs and is triggered by release of 5-HT3 in a cascade of neuronal event involving both the central nervous system and the gastrointestinal tract. The 5-HT3 receptor has been demonstrated to selectively participate in the emetic response. Palostar 0.5 mg works by blocking the actions of Serotonin, associated with nausea and vomiting, at 5-HTs receptor. It is likely that Palostar 0.5 mg works in the small intestine but it may also work in the brain.Pharmacokinetics: Palostar 0.5 mg exhibits linear dose-proportional pharmacokinetics over the doserange 1-90 pg/kg in healthy subjects and in patients with cancer. In cancer patients receiving single intravenous doses of Palostar 0.5 mg in this dose range, the mean maximum plasma concentration (Cmax) ranges from 0.89 to 336 ng/ml and the area under the plasma concentration-time curve from zero to infinity (AUCo-co) ranges from 13.8 to 957 ng.h/ml. Palostar 0.5 mg has a volume of distribution of approximately 6.9-7.9 L/kg, with approximately 62% bound to plasma proteins. Approximately 50% of Palostar 0.5 mg is metabolized into two inactive metabolites that exhibit 65 years of age.Use in Children: (1 month to 10 years): A single IV dose at 20 mcg/kg body weight. Which maximum dose is 1.5 mg.Use in patients with impaired renal and hepatic function: No dosage adjustment is recommended in patients with renal and hepatic dysfunction.

Pep 100 mlPep 100 ml is indicated in zinc deficiency and/or zinc losing conditions. Zinc deficiency can occur as a result of inadequate diet or malabsorption. Excessive loss of zinc can occur in trauma, burns, diarrhoea and protein losing conditions. A zinc supplement is given until clinical improvement occurs but it may need to be continued in severe malabsorption, metabolic disease or in zinc losing states.Theropeutic ClassSpecific mineral preparationsPharmacologyZinc sulphate monohydrate is an essential trace element and is involved in a number of body enzyme systems. The body needs zinc for normal growth and health. Zinc is also vital for sexual maturation and reproduction, dark vision adaptation, olfactory and gustatory activity, insulin storage & release and for a variety of host immune defenses. Zinc deficiency may lead to impaired immune function, delayed wound healing, a decrease in sense of taste and smell, a reduced ability to fight infections, poor night vision, increased risk of abortion, alopecia, mental lethargy, skin changes and poor development of reproductive organs.Dosage of Pep 100 mlChild under 10 kg: 5 ml (1 teaspoonful) 2 times daily after food.Child between 10-30 kg: 10 ml (2 teaspoonfuls) 1-3 times daily after food.Adults and child over 30 kg: 20 ml (4 teaspoonfuls) 1-3 times daily after food.This drug is most effective if they are taken at least 1 hour before or 2 hour after meals. However, if causes stomach upset, this may be taken with a meal.Administration of Pep 100 mlFor dispersible tablet- Place the tablet in a teaspoon Add adequate amount of water Let the tablet dissolve completely Give the entire spoonful solution Interaction of Pep 100 mlConcomitant intake of a tetracycline and zinc may decrease the absorption of both the tetracycline and zinc. Similarly concomitant administration of zinc and quinolone drug may also decrease the absorption of both. Concomitant intake of penicillamine and zinc may decrese absorption of zinc.ContraindicationsIt is contraindicated in those who are hypersensitive to any component of the ingredient of this preparation.Side Effects of Pep 100 mlZinc may cause nausea, vomiting, diarrhoea, stomach upset, heartburn and gastritis.Pregnancy & LactationThe safety of this product in human pregnancy has not been established. Zinc crosses the placenta and is present in breast milk.Precautions & WarningsIn acute renal failure, zinc accumulation may occur in body; so dose adjustment is needed.Storage ConditionsKeep in a dry place away from light and heat. Keep out of the reach of children.

Rovex 10 mgRovex 10 mg is indicated in- Heterozygous Hypercholesterolemia (Familial and Non familial) Homozygous Hypercholesterolemia (Familial) Mixed Dyslipidemia (Fredrickson Type IIa and IIb) Primary prevention of cardiovascular diseaseTheropeutic ClassOther Anti-anginal & Anti-ischaemic drugs, StatinsPharmacologyRovex 10 mg is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. It produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, the solution inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.Dosage of Rovex 10 mgDose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mgHoFH: Starting dose 20 mg/day.Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.Administration of Rovex 10 mgRovex 10 mg can be taken with or without food, at any time of day.Interaction of Rovex 10 mgRemarkable drug interactions of Rovex 10 mg are: Cyclosporine: Combining these medications increases its exposure. The recommended dose should not exceed 5 mg once daily. Gemfibrosil: It is advisable to avoid combining these drugs. If necessary, limit the dosage to 10 mg once daily when used together. Lopinavir/Ritonavir or atazanavir/ritonavir: When used in combination, these medications can elevate its exposure. The recommended dose should be limited to 10 mg once daily. Coumarin anticoagulants: Combining with coumarin anticoagulants can prolong the international normalized ratio (INR). Achieve a stable INR before initiating treatment and monitor it frequently until it remains stable during therapy. Concomitant lipid-lowering therapies: When used with fibrates and niacin products, there may be an increased risk of skeletal muscle effects. ContraindicationsRovex 10 mg is contraindicated if- Known hypersensitivity to product components Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels Pregnant women and women who may become pregnant Nursing mothersSide Effects of Rovex 10 mgRovex 10 mg is generally well tolerated. The most frequent adverse events thought to be related to the medicine were headache, myalgia, constipation, asthenia, abdominal pain and nausea.Pregnancy & LactationThe safety in pregnant women has not been established. It is not known whether Rovex 10 mg is excreted in human milk or not.Precautions & WarningsSkeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rovex 10 mg can be discontinued if signs or symptoms appear.Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur. Liver enzymes should be monitored before and during treatmentStorage ConditionsKeep below 30oC temperature, protected from light & moisture. Keep out of the reach of children.Use In Special PopulationsUse in children: The safety and effectiveness in pediatric patients have not been established.

Rovex 5 mgRovex 5 mg is indicated in- Heterozygous Hypercholesterolemia (Familial and Non familial) Homozygous Hypercholesterolemia (Familial) Mixed Dyslipidemia (Fredrickson Type IIa and IIb) Primary prevention of cardiovascular diseaseTheropeutic ClassOther Anti-anginal & Anti-ischaemic drugs, StatinsPharmacologyRovex 5 mg is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. It produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, the solution inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.Dosage of Rovex 5 mgDose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mgHoFH: Starting dose 20 mg/day.Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.Administration of Rovex 5 mgRovex 5 mg can be taken with or without food, at any time of day.Interaction of Rovex 5 mgRemarkable drug interactions of Rovex 5 mg are: Cyclosporine: Combining these medications increases its exposure. The recommended dose should not exceed 5 mg once daily. Gemfibrosil: It is advisable to avoid combining these drugs. If necessary, limit the dosage to 10 mg once daily when used together. Lopinavir/Ritonavir or atazanavir/ritonavir: When used in combination, these medications can elevate its exposure. The recommended dose should be limited to 10 mg once daily. Coumarin anticoagulants: Combining with coumarin anticoagulants can prolong the international normalized ratio (INR). Achieve a stable INR before initiating treatment and monitor it frequently until it remains stable during therapy. Concomitant lipid-lowering therapies: When used with fibrates and niacin products, there may be an increased risk of skeletal muscle effects. ContraindicationsRovex 5 mg is contraindicated if- Known hypersensitivity to product components Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels Pregnant women and women who may become pregnant Nursing mothersSide Effects of Rovex 5 mgRovex 5 mg is generally well tolerated. The most frequent adverse events thought to be related to the medicine were headache, myalgia, constipation, asthenia, abdominal pain and nausea.Pregnancy & LactationThe safety in pregnant women has not been established. It is not known whether Rovex 5 mg is excreted in human milk or not.Precautions & WarningsSkeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rovex 5 mg can be discontinued if signs or symptoms appear.Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur. Liver enzymes should be monitored before and during treatmentStorage ConditionsKeep below 30oC temperature, protected from light & moisture. Keep out of the reach of children.Use In Special PopulationsUse in children: The safety and effectiveness in pediatric patients have not been established.